GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS)

Osteoarthritis Clinical Trial

— GI-REASONS  

Official title:

Gastrointestinal (GI) Randomized Event And Safety Open-Label NSAID Study (GI-Reasons): A Randomized, Open-Label, Blinded-Endpoint, Parallel-Group Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS) In Osteoarthritis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373685
• Other study ID #: A3191331
• Status: Completed
• Phase: Phase 4
• Start date: October 2006
• Est. completion date: November 2010

Study information

• Verified date: March 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8067
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 99 Years

Eligibility

Inclusion Criteria:

• Male or female patients of at least 55 years of age with a clinical diagnosis of OA who are expected to require daily prescription anti-inflammatory analgesic therapy for arthritis symptom management and for whom either celecoxib or a nsNSAID is an appropriate treatment option.

Exclusion Criteria:

• GI ulcer hemorrhage or active GD ulceration less than 90 days prior to screening visit.

• Patients with a history of myocardial infarction, unstable angina, ischemic or hemorrhagic stroke, transient ischemic attack, previous revascularization procedure to coronary, carotid, cerebral, renal, aortic or peripheral arterial vasculature.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Celecoxib
open-label
• Any commercially available NSAID with the indication for osteoarthritis
dosing as per USPI label related to the chosen commercially marketed NSAID

Locations

Country	Name	City	State
Puerto Rico	Pfizer Investigational Site	Aguas Buenas
Puerto Rico	Pfizer Investigational Site	Aguns Buenoas
Puerto Rico	Pfizer Investigational Site	Aibonito
Puerto Rico	Pfizer Investigational Site	Bayamon
Puerto Rico	Pfizer Investigational Site	Bayamon
Puerto Rico	Pfizer Investigational Site	Caguas
Puerto Rico	Pfizer Investigational Site	Carolina
Puerto Rico	Pfizer Investigational Site	Cayey
Puerto Rico	Pfizer Investigational Site	Cialis
Puerto Rico	Pfizer Investigational Site	Cidra
Puerto Rico	Pfizer Investigational Site	Hato Rey
Puerto Rico	Pfizer Investigational Site	Juncas
Puerto Rico	Pfizer Investigational Site	Juncos
Puerto Rico	Pfizer Investigational Site	Las Piedras
Puerto Rico	Pfizer Investigational Site	Levittown
Puerto Rico	Pfizer Investigational Site	Loiza
Puerto Rico	Pfizer Investigational Site	Manati
Puerto Rico	Pfizer Investigational Site	Orocovis
Puerto Rico	Pfizer Investigational Site	Rio Piedras
Puerto Rico	Pfizer Investigational Site	Rio Piedras
Puerto Rico	Pfizer Investigational Site	San Juan
Puerto Rico	Pfizer Investigational Site	San Juan
Puerto Rico	Pfizer Investigational Site	San Juan
Puerto Rico	Pfizer Investigational Site	San Juan
Puerto Rico	Pfizer Investigational Site	Santa Isabel
Puerto Rico	Pfizer Investigational Site	Santurce
Puerto Rico	Pfizer Investigational Site	Trujillo Alto
United States	Pfizer Investigational Site	'Aiea	Hawaii
United States	Pfizer Investigational Site	Abbeville	Alabama
United States	Pfizer Investigational Site	Akron	Ohio
United States	Pfizer Investigational Site	Albany	New York
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Alexander City	Alabama
United States	Pfizer Investigational Site	Alexandria	Louisiana
United States	Pfizer Investigational Site	Alliance	Nebraska
United States	Pfizer Investigational Site	Altamonte Springs	Florida
United States	Pfizer Investigational Site	Amarillo	Texas
United States	Pfizer Investigational Site	Ames	Iowa
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	Anderson	South Carolina
United States	Pfizer Investigational Site	Annandale	Virginia
United States	Pfizer Investigational Site	Apopka	Florida
United States	Pfizer Investigational Site	Arkansas City	Kansas
United States	Pfizer Investigational Site	Arlington	Texas
United States	Pfizer Investigational Site	Arlington Heights	Illinois
United States	Pfizer Investigational Site	Asheboro	North Carolina
United States	Pfizer Investigational Site	Aston	Pennsylvania
United States	Pfizer Investigational Site	Athens	Georgia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Attleboro	Massachusetts
United States	Pfizer Investigational Site	Audubon	Pennsylvania
United States	Pfizer Investigational Site	Aurora	Colorado
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Avon	Connecticut
United States	Pfizer Investigational Site	Azle	Texas
United States	Pfizer Investigational Site	Bainbridge	Georgia
United States	Pfizer Investigational Site	Bakersfield	California
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Baton Rouge	Louisiana
United States	Pfizer Investigational Site	Bay Minette	Alabama
United States	Pfizer Investigational Site	Beatrice	Nebraska
United States	Pfizer Investigational Site	Bel Air	Maryland
United States	Pfizer Investigational Site	Bellevue	Washington
United States	Pfizer Investigational Site	Bellflower	California
United States	Pfizer Investigational Site	Belvidere	New Jersey
United States	Pfizer Investigational Site	Belzoni	Mississippi
United States	Pfizer Investigational Site	Bensalem	Pennsylvania
United States	Pfizer Investigational Site	Berkley	Michigan
United States	Pfizer Investigational Site	Berlin	New Jersey
United States	Pfizer Investigational Site	Bermuda Dunes	California
United States	Pfizer Investigational Site	Bethany	Oklahoma
United States	Pfizer Investigational Site	Bethlehem	Pennsylvania
United States	Pfizer Investigational Site	Beverly Hills	Florida
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Blackwood	New Jersey
United States	Pfizer Investigational Site	Bladensburg	Maryland
United States	Pfizer Investigational Site	Bluefield	Virginia
United States	Pfizer Investigational Site	Bluffton	South Carolina
United States	Pfizer Investigational Site	Boardman	Ohio
United States	Pfizer Investigational Site	Bolivar	Tennessee
United States	Pfizer Investigational Site	Boone	North Carolina
United States	Pfizer Investigational Site	Bountiful	Utah
United States	Pfizer Investigational Site	Bowling Green	Kentucky
United States	Pfizer Investigational Site	Boynton Beach	Florida
United States	Pfizer Investigational Site	Brewster	Connecticut
United States	Pfizer Investigational Site	Bridgeport	New Jersey
United States	Pfizer Investigational Site	Bridgeton	New Jersey
United States	Pfizer Investigational Site	Brighton	Michigan
United States	Pfizer Investigational Site	Bristol	Pennsylvania
United States	Pfizer Investigational Site	Broken Bow	Nebraska
United States	Pfizer Investigational Site	Brookfield	Connecticut
United States	Pfizer Investigational Site	Brooklyn	New York
United States	Pfizer Investigational Site	Brooklyn	New York
United States	Pfizer Investigational Site	Broomall	Pennsylvania
United States	Pfizer Investigational Site	Brownsburg	Indiana
United States	Pfizer Investigational Site	Buena Park	California
United States	Pfizer Investigational Site	Buena Park	California
United States	Pfizer Investigational Site	Bunn	North Carolina
United States	Pfizer Investigational Site	Burnsville	West Virginia
United States	Pfizer Investigational Site	Butler	Pennsylvania
United States	Pfizer Investigational Site	Cadillac	Michigan
United States	Pfizer Investigational Site	Cairo	Georgia
United States	Pfizer Investigational Site	Calhoun	Georgia
United States	Pfizer Investigational Site	Camp Hill	Pennsylvania
United States	Pfizer Investigational Site	Canton	Ohio
United States	Pfizer Investigational Site	Carlisle	Ohio
United States	Pfizer Investigational Site	Carnegie	Pennsylvania
United States	Pfizer Investigational Site	Carrollton	Texas
United States	Pfizer Investigational Site	Carrollton	Texas
United States	Pfizer Investigational Site	Carson	California
United States	Pfizer Investigational Site	Cartersville	Georgia
United States	Pfizer Investigational Site	Cedar Rapids	Iowa
United States	Pfizer Investigational Site	Centerville	Ohio
United States	Pfizer Investigational Site	Cerritos	California
United States	Pfizer Investigational Site	Chandler	Arizona
United States	Pfizer Investigational Site	Chardon	Ohio
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Chatham	Virginia
United States	Pfizer Investigational Site	Chattanooga	Tennessee
United States	Pfizer Investigational Site	Chelsea	Michigan
United States	Pfizer Investigational Site	Chesapeake	Virginia
United States	Pfizer Investigational Site	Chester	Pennsylvania
United States	Pfizer Investigational Site	Chesterland	Ohio
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Chicora	Pennsylvania
United States	Pfizer Investigational Site	Chipley	Florida
United States	Pfizer Investigational Site	Chula Vista	California
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Clarkston	Michigan
United States	Pfizer Investigational Site	Clarksville	Tennessee
United States	Pfizer Investigational Site	Clearwater	Florida
United States	Pfizer Investigational Site	Clementon	New Jersey
United States	Pfizer Investigational Site	Clemson	South Carolina
United States	Pfizer Investigational Site	Clermont	Florida
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Clinton	South Carolina
United States	Pfizer Investigational Site	Clinton	Utah
United States	Pfizer Investigational Site	Cocoa	Florida
United States	Pfizer Investigational Site	Cocoa Beach	Florida
United States	Pfizer Investigational Site	College Park	Maryland
United States	Pfizer Investigational Site	Colleyville	Texas
United States	Pfizer Investigational Site	Collierville	Tennessee
United States	Pfizer Investigational Site	Colorado Springs	Colorado
United States	Pfizer Investigational Site	Colorado Springs	Colorado
United States	Pfizer Investigational Site	Columbia	South Carolina
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Columbus	Georgia
United States	Pfizer Investigational Site	Coral Springs	Florida
United States	Pfizer Investigational Site	Corpus Christi	Texas
United States	Pfizer Investigational Site	Cortland	Ohio
United States	Pfizer Investigational Site	Cos Cob	Connecticut
United States	Pfizer Investigational Site	Covington	Georgia
United States	Pfizer Investigational Site	Cranston	Rhode Island
United States	Pfizer Investigational Site	Cresson	Pennsylvania
United States	Pfizer Investigational Site	Crystal River	Florida
United States	Pfizer Investigational Site	Cudahy	California
United States	Pfizer Investigational Site	Cullman	Alabama
United States	Pfizer Investigational Site	Cumming	Georgia
United States	Pfizer Investigational Site	Cutler Bay	Florida
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallastown	Pennsylvania
United States	Pfizer Investigational Site	Danville	Illinois
United States	Pfizer Investigational Site	Danville	Virginia
United States	Pfizer Investigational Site	Dauphin	Pennsylvania
United States	Pfizer Investigational Site	Davie	Florida
United States	Pfizer Investigational Site	Dawsonville	Georgia
United States	Pfizer Investigational Site	Dayton	Ohio
United States	Pfizer Investigational Site	Daytona Beach	Florida
United States	Pfizer Investigational Site	Daytona Beach	Florida
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	DeFuniak Springs	Florida
United States	Pfizer Investigational Site	DeKalb	Illinois
United States	Pfizer Investigational Site	DeLand	Florida
United States	Pfizer Investigational Site	Delaware	Ohio
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Des Moines	Iowa
United States	Pfizer Investigational Site	Des Moines	Iowa
United States	Pfizer Investigational Site	DeSoto	Texas
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	Dothan	Alabama
United States	Pfizer Investigational Site	Dothan	Alabama
United States	Pfizer Investigational Site	Downingtown	Pennsylvania
United States	Pfizer Investigational Site	Draffenville	Kentucky
United States	Pfizer Investigational Site	Dubuque	Iowa
United States	Pfizer Investigational Site	Duncansville	Pennsylvania
United States	Pfizer Investigational Site	Dunnellon	Florida
United States	Pfizer Investigational Site	Dunwoody	Georgia
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	East Providence	Rhode Island
United States	Pfizer Investigational Site	East Syracuse	New York
United States	Pfizer Investigational Site	Edmond	Oklahoma
United States	Pfizer Investigational Site	Egg Harbor Township	New Jersey
United States	Pfizer Investigational Site	El Cajon	California
United States	Pfizer Investigational Site	El Segundo	California
United States	Pfizer Investigational Site	Elgin	Illinois
United States	Pfizer Investigational Site	Elizabeth	New Jersey
United States	Pfizer Investigational Site	Elizabeth	New Jersey
United States	Pfizer Investigational Site	Elizabeth City	North Carolina
United States	Pfizer Investigational Site	Elkton	Maryland
United States	Pfizer Investigational Site	Ellicott City	Maryland
United States	Pfizer Investigational Site	Elmhurst	New York
United States	Pfizer Investigational Site	Encino	California
United States	Pfizer Investigational Site	Erie	Pennsylvania
United States	Pfizer Investigational Site	Erie	Pennsylvania
United States	Pfizer Investigational Site	Escondido	California
United States	Pfizer Investigational Site	Evansville	Indiana
United States	Pfizer Investigational Site	Evansville	Indiana
United States	Pfizer Investigational Site	Evergreen Park	Illinois
United States	Pfizer Investigational Site	Fair Haven	Michigan
United States	Pfizer Investigational Site	Fairborn	Ohio
United States	Pfizer Investigational Site	Fairview Heights	Illinois
United States	Pfizer Investigational Site	Fall River	Massachusetts
United States	Pfizer Investigational Site	Far Rockaway	New York
United States	Pfizer Investigational Site	Farmers Branch	Texas
United States	Pfizer Investigational Site	Fayetteville	New York
United States	Pfizer Investigational Site	Fenton	Michigan
United States	Pfizer Investigational Site	Flanders	New Jersey
United States	Pfizer Investigational Site	Fleetwood	Pennsylvania
United States	Pfizer Investigational Site	Flint	Michigan
United States	Pfizer Investigational Site	Florissant	Missouri
United States	Pfizer Investigational Site	Flossmoor	Illinois
United States	Pfizer Investigational Site	Flourtown	Pennsylvania
United States	Pfizer Investigational Site	Flushing	New York
United States	Pfizer Investigational Site	Flushing	New York
United States	Pfizer Investigational Site	Fogelsville	Pennsylvania
United States	Pfizer Investigational Site	Forest Hills	New York
United States	Pfizer Investigational Site	Fort Collins	Colorado
United States	Pfizer Investigational Site	Fort Dodge	Iowa
United States	Pfizer Investigational Site	Fort Lauderdale	Florida
United States	Pfizer Investigational Site	Fort Myers	Florida
United States	Pfizer Investigational Site	Fort Wayne	Indiana
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Fortuna	California
United States	Pfizer Investigational Site	Franklin	Ohio
United States	Pfizer Investigational Site	Frederick	Maryland
United States	Pfizer Investigational Site	Freehold	New Jersey
United States	Pfizer Investigational Site	Fremont	Nebraska
United States	Pfizer Investigational Site	Fremont	California
United States	Pfizer Investigational Site	Fresno	California
United States	Pfizer Investigational Site	Fresno	California
United States	Pfizer Investigational Site	Frisco	Texas
United States	Pfizer Investigational Site	Gaffney	South Carolina
United States	Pfizer Investigational Site	Gainesville	Florida
United States	Pfizer Investigational Site	Gainesville	Georgia
United States	Pfizer Investigational Site	Garden Grove	California
United States	Pfizer Investigational Site	Garden Grove	California
United States	Pfizer Investigational Site	Garland	Texas
United States	Pfizer Investigational Site	Gastonia	North Carolina
United States	Pfizer Investigational Site	Geneva	Alabama
United States	Pfizer Investigational Site	Genoa	Ohio
United States	Pfizer Investigational Site	Germantown	Tennessee
United States	Pfizer Investigational Site	Glendale	Arizona
United States	Pfizer Investigational Site	Glendora	New Jersey
United States	Pfizer Investigational Site	Golden	Colorado
United States	Pfizer Investigational Site	Grand Island	Nebraska
United States	Pfizer Investigational Site	Grand Ledge	Michigan
United States	Pfizer Investigational Site	Grand Prairie	Texas
United States	Pfizer Investigational Site	Grand Prairie	Texas
United States	Pfizer Investigational Site	Grand Rapids	Michigan
United States	Pfizer Investigational Site	Grants Pass	Oregon
United States	Pfizer Investigational Site	Grapevine	Texas
United States	Pfizer Investigational Site	Green Cove Springs	Florida
United States	Pfizer Investigational Site	Green Valley	Arizona
United States	Pfizer Investigational Site	Greenbrae	California
United States	Pfizer Investigational Site	Greensboro	North Carolina
United States	Pfizer Investigational Site	Greensburg	Pennsylvania
United States	Pfizer Investigational Site	Greenville	South Carolina
United States	Pfizer Investigational Site	Greenville	South Carolina
United States	Pfizer Investigational Site	Greenville	South Carolina
United States	Pfizer Investigational Site	Greenville	South Carolina
United States	Pfizer Investigational Site	Greenville	North Carolina
United States	Pfizer Investigational Site	Greenville	Illinois
United States	Pfizer Investigational Site	Greer	South Carolina
United States	Pfizer Investigational Site	Gulf Shores	Alabama
United States	Pfizer Investigational Site	Guntersville	Alabama
United States	Pfizer Investigational Site	Hallandale Beach	Florida
United States	Pfizer Investigational Site	Hamden	Connecticut
United States	Pfizer Investigational Site	Hampton	Georgia
United States	Pfizer Investigational Site	Hampton	Virginia
United States	Pfizer Investigational Site	Hanna City	Illinois
United States	Pfizer Investigational Site	Harbor City	California
United States	Pfizer Investigational Site	Harrisburg	Pennsylvania
United States	Pfizer Investigational Site	Harrisburg	Pennsylvania
United States	Pfizer Investigational Site	Hartford	Kentucky
United States	Pfizer Investigational Site	Hatboro	Pennsylvania
United States	Pfizer Investigational Site	Hatfield	Pennsylvania
United States	Pfizer Investigational Site	Hattiesburg	Mississippi
United States	Pfizer Investigational Site	Hemet	California
United States	Pfizer Investigational Site	Henderson	Texas
United States	Pfizer Investigational Site	Hendersonville	Tennessee
United States	Pfizer Investigational Site	Hermiston	Oregon
United States	Pfizer Investigational Site	Hialeah	Florida
United States	Pfizer Investigational Site	Hialeah	Florida
United States	Pfizer Investigational Site	Hialeah	Florida
United States	Pfizer Investigational Site	Hinesville	Georgia
United States	Pfizer Investigational Site	Hobart	Indiana
United States	Pfizer Investigational Site	Hollywood	Florida
United States	Pfizer Investigational Site	Hollywood	Florida
United States	Pfizer Investigational Site	Holmdel	New Jersey
United States	Pfizer Investigational Site	Honaker	Virginia
United States	Pfizer Investigational Site	Honolulu	Hawaii
United States	Pfizer Investigational Site	Honolulu	Hawaii
United States	Pfizer Investigational Site	Hot Springs	Arkansas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Humble	Texas
United States	Pfizer Investigational Site	Humboldt	Tennessee
United States	Pfizer Investigational Site	Huntersville	North Carolina
United States	Pfizer Investigational Site	Huntington Beach	California
United States	Pfizer Investigational Site	Huntington Park	California
United States	Pfizer Investigational Site	Huntsville	Alabama
United States	Pfizer Investigational Site	Huntsville	Alabama
United States	Pfizer Investigational Site	Hurst	Texas
United States	Pfizer Investigational Site	Incline Village	Nevada
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Interlochen	Michigan
United States	Pfizer Investigational Site	Irvine	California
United States	Pfizer Investigational Site	Irving	Texas
United States	Pfizer Investigational Site	Irving	Texas
United States	Pfizer Investigational Site	Jackson	Mississippi
United States	Pfizer Investigational Site	Jackson	Mississippi
United States	Pfizer Investigational Site	Jackson	Mississippi
United States	Pfizer Investigational Site	Jackson	Missouri
United States	Pfizer Investigational Site	Jacksonville	North Carolina
United States	Pfizer Investigational Site	Jacksonville	Alabama
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Jeannette	Pennsylvania
United States	Pfizer Investigational Site	Jefferson City	Missouri
United States	Pfizer Investigational Site	Jefferson Hills	Pennsylvania
United States	Pfizer Investigational Site	Jena	Louisiana
United States	Pfizer Investigational Site	Johnstown	Pennsylvania
United States	Pfizer Investigational Site	Jonesboro	Louisiana
United States	Pfizer Investigational Site	Jupiter	Florida
United States	Pfizer Investigational Site	Kalamazoo	Michigan
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Kansas City	Kansas
United States	Pfizer Investigational Site	Kansas City	Kansas
United States	Pfizer Investigational Site	Katy	Texas
United States	Pfizer Investigational Site	Key Biscayne	Florida
United States	Pfizer Investigational Site	Killeen	Texas
United States	Pfizer Investigational Site	King Of Prussia	Pennsylvania
United States	Pfizer Investigational Site	Kingsport	Tennessee
United States	Pfizer Investigational Site	Kinston	North Carolina
United States	Pfizer Investigational Site	Kissimmee	Florida
United States	Pfizer Investigational Site	La Jolla	California
United States	Pfizer Investigational Site	La Palma	California
United States	Pfizer Investigational Site	Lake Charles	Louisiana
United States	Pfizer Investigational Site	Lake Success	New York
United States	Pfizer Investigational Site	Lake Worth	Florida
United States	Pfizer Investigational Site	Lakewood	Colorado
United States	Pfizer Investigational Site	Lakewood	Colorado
United States	Pfizer Investigational Site	Lancaster	Pennsylvania
United States	Pfizer Investigational Site	Landrum	South Carolina
United States	Pfizer Investigational Site	Lansdale	Pennsylvania
United States	Pfizer Investigational Site	Lansdale	Pennsylvania
United States	Pfizer Investigational Site	Lansing	Michigan
United States	Pfizer Investigational Site	Lansing	Michigan
United States	Pfizer Investigational Site	LaPorte	Indiana
United States	Pfizer Investigational Site	Largo	Florida
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Lawrenceville	Georgia
United States	Pfizer Investigational Site	Layton	Utah
United States	Pfizer Investigational Site	Leesburg	Virginia
United States	Pfizer Investigational Site	Lenoir	North Carolina
United States	Pfizer Investigational Site	Lewisburg	West Virginia
United States	Pfizer Investigational Site	Lewiston	New York
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Lincoln Park	New Jersey
United States	Pfizer Investigational Site	Linden	New Jersey
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Liverpool	New York
United States	Pfizer Investigational Site	Livonia	Michigan
United States	Pfizer Investigational Site	Long Beach	California
United States	Pfizer Investigational Site	Long Beach	California
United States	Pfizer Investigational Site	Long Beach	California
United States	Pfizer Investigational Site	Los Alamos	New Mexico
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Los Banos	California
United States	Pfizer Investigational Site	Los Gatos	California
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Lyndhurst	Ohio
United States	Pfizer Investigational Site	Macon	Georgia
United States	Pfizer Investigational Site	Magee	Mississippi
United States	Pfizer Investigational Site	Marietta	Ohio
United States	Pfizer Investigational Site	Marina Del Rey	California
United States	Pfizer Investigational Site	Marion	Ohio
United States	Pfizer Investigational Site	Marion	South Carolina
United States	Pfizer Investigational Site	Mason	Ohio
United States	Pfizer Investigational Site	Maynardville	Tennessee
United States	Pfizer Investigational Site	McConnelsville	Ohio
United States	Pfizer Investigational Site	McCook	Nebraska
United States	Pfizer Investigational Site	McKinney	Texas
United States	Pfizer Investigational Site	McKinney	Texas
United States	Pfizer Investigational Site	Medford	Oregon
United States	Pfizer Investigational Site	Melbourne	Florida
United States	Pfizer Investigational Site	Melbourne	Florida
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Merced	California
United States	Pfizer Investigational Site	Mesa	Arizona
United States	Pfizer Investigational Site	Mesa	Arizona
United States	Pfizer Investigational Site	Metairie	Louisiana
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miami Beach	Florida
United States	Pfizer Investigational Site	Middleburg Heights	Ohio
United States	Pfizer Investigational Site	Middletown	Ohio
United States	Pfizer Investigational Site	Midland	Texas
United States	Pfizer Investigational Site	Midland Park	New Jersey
United States	Pfizer Investigational Site	Milford	Connecticut
United States	Pfizer Investigational Site	Millvale	Pennsylvania
United States	Pfizer Investigational Site	Mishawaka	Indiana
United States	Pfizer Investigational Site	Mission	Kansas
United States	Pfizer Investigational Site	Mission Viejo	California
United States	Pfizer Investigational Site	Missoula	Montana
United States	Pfizer Investigational Site	Missouri City	Texas
United States	Pfizer Investigational Site	Mobile	Alabama
United States	Pfizer Investigational Site	Moline	Illinois
United States	Pfizer Investigational Site	Monroe	Louisiana
United States	Pfizer Investigational Site	Monroe	Louisiana
United States	Pfizer Investigational Site	Monroe	North Carolina
United States	Pfizer Investigational Site	Montebello	California
United States	Pfizer Investigational Site	Monterey Park	California
United States	Pfizer Investigational Site	Montgomery	Alabama
United States	Pfizer Investigational Site	Moore	Oklahoma
United States	Pfizer Investigational Site	Morristown	Tennessee
United States	Pfizer Investigational Site	Morrisville	Pennsylvania
United States	Pfizer Investigational Site	Mount Airy	Maryland
United States	Pfizer Investigational Site	Mount Sterling	Kentucky
United States	Pfizer Investigational Site	Moweaqua	Illinois
United States	Pfizer Investigational Site	Muscle Shoals	Alabama
United States	Pfizer Investigational Site	Myrtle Beach	South Carolina
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Natchitoches	Louisiana
United States	Pfizer Investigational Site	Nederland	Texas
United States	Pfizer Investigational Site	New Bern	North Carolina
United States	Pfizer Investigational Site	New Braunfels	Texas
United States	Pfizer Investigational Site	New Hartford	New York
United States	Pfizer Investigational Site	New Haven	Indiana
United States	Pfizer Investigational Site	New Lexington	Ohio
United States	Pfizer Investigational Site	New Orleans	Louisiana
United States	Pfizer Investigational Site	New Tazewell	Tennessee
United States	Pfizer Investigational Site	New Windsor	New York
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Newark	Delaware
United States	Pfizer Investigational Site	Newberry	South Carolina
United States	Pfizer Investigational Site	Newport Beach	California
United States	Pfizer Investigational Site	Newport Beach	California
United States	Pfizer Investigational Site	Newton	Kansas
United States	Pfizer Investigational Site	Niceville	Florida
United States	Pfizer Investigational Site	Norfolk	Virginia
United States	Pfizer Investigational Site	North Andover	Massachusetts
United States	Pfizer Investigational Site	North Arlington	New Jersey
United States	Pfizer Investigational Site	North Dartmouth	Massachusetts
United States	Pfizer Investigational Site	North Miami	Florida
United States	Pfizer Investigational Site	North Myrtle Beach	South Carolina
United States	Pfizer Investigational Site	North Richland Hills	Texas
United States	Pfizer Investigational Site	Northern Cambria	Pennsylvania
United States	Pfizer Investigational Site	Northglenn	Colorado
United States	Pfizer Investigational Site	O'Fallon	Illinois
United States	Pfizer Investigational Site	Ocala	Florida
United States	Pfizer Investigational Site	Odessa	Texas
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Olean	New York
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Orange City	Florida
United States	Pfizer Investigational Site	Orangeburg	South Carolina
United States	Pfizer Investigational Site	Orangeburg	South Carolina
United States	Pfizer Investigational Site	Orchard Park	New York
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Ormond Beach	Florida
United States	Pfizer Investigational Site	Orrville	Ohio
United States	Pfizer Investigational Site	Oviedo	Florida
United States	Pfizer Investigational Site	Ozark	Alabama
United States	Pfizer Investigational Site	Paducah	Kentucky
United States	Pfizer Investigational Site	Palm Bay	Florida
United States	Pfizer Investigational Site	Palm Harbor	Florida
United States	Pfizer Investigational Site	Panama City	Florida
United States	Pfizer Investigational Site	Paragould	Arkansas
United States	Pfizer Investigational Site	Paramount	California
United States	Pfizer Investigational Site	Parchment	Michigan
United States	Pfizer Investigational Site	Parkland	Florida
United States	Pfizer Investigational Site	Pasco	Washington
United States	Pfizer Investigational Site	Passaic	New Jersey
United States	Pfizer Investigational Site	Peak	South Carolina
United States	Pfizer Investigational Site	Pekin	Illinois
United States	Pfizer Investigational Site	Pell City	Alabama
United States	Pfizer Investigational Site	Pembroke Pines	Florida
United States	Pfizer Investigational Site	Pembroke Pines	Florida
United States	Pfizer Investigational Site	Penndel	Pennsylvania
United States	Pfizer Investigational Site	Pennsburg	Pennsylvania
United States	Pfizer Investigational Site	Peoria	Illinois
United States	Pfizer Investigational Site	Peoria	Illinois
United States	Pfizer Investigational Site	Peoria	Illinois
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Phoenixville	Pennsylvania
United States	Pfizer Investigational Site	Picayune	Mississippi
United States	Pfizer Investigational Site	Pigeon	Michigan
United States	Pfizer Investigational Site	Pine Bluff	Arkansas
United States	Pfizer Investigational Site	Pinecrest	Florida
United States	Pfizer Investigational Site	Pismo Beach	California
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Plainview	New York
United States	Pfizer Investigational Site	Plano	Texas
United States	Pfizer Investigational Site	Plano	Texas
United States	Pfizer Investigational Site	Plano	Texas
United States	Pfizer Investigational Site	Plantation	Florida
United States	Pfizer Investigational Site	Plantation	Florida
United States	Pfizer Investigational Site	Pleasanton	Texas
United States	Pfizer Investigational Site	Port Carbon	Pennsylvania
United States	Pfizer Investigational Site	Port Charlotte	Florida
United States	Pfizer Investigational Site	Port Gibson	Mississippi
United States	Pfizer Investigational Site	Port Orange	Florida
United States	Pfizer Investigational Site	Port Richey	Florida
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Portsmouth	Virginia
United States	Pfizer Investigational Site	Poteet	Texas
United States	Pfizer Investigational Site	Pottstown	Pennsylvania
United States	Pfizer Investigational Site	Pratt	Kansas
United States	Pfizer Investigational Site	Prentiss	Mississippi
United States	Pfizer Investigational Site	Prince Frederick	Maryland
United States	Pfizer Investigational Site	Providence	Rhode Island
United States	Pfizer Investigational Site	Pueblo	Colorado
United States	Pfizer Investigational Site	Quincy	Illinois
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Rancho Cucamonga	California
United States	Pfizer Investigational Site	Reading	Pennsylvania
United States	Pfizer Investigational Site	Redlands	California
United States	Pfizer Investigational Site	Reseda	California
United States	Pfizer Investigational Site	Rialto	California
United States	Pfizer Investigational Site	Richardson	Texas
United States	Pfizer Investigational Site	Richmond	Texas
United States	Pfizer Investigational Site	Richmond	Kentucky
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Ridgefield	Connecticut
United States	Pfizer Investigational Site	Riverdale	Maryland
United States	Pfizer Investigational Site	Riverside	California
United States	Pfizer Investigational Site	Rockville	Maryland
United States	Pfizer Investigational Site	Rockville	Maryland
United States	Pfizer Investigational Site	Rockwall	Texas
United States	Pfizer Investigational Site	Ronceverte	West Virginia
United States	Pfizer Investigational Site	Roswell	Georgia
United States	Pfizer Investigational Site	Rowland Heights	California
United States	Pfizer Investigational Site	Rye Brook	New York
United States	Pfizer Investigational Site	Sacramento	California
United States	Pfizer Investigational Site	Saginaw	Michigan
United States	Pfizer Investigational Site	Saint Clair Shores	Michigan
United States	Pfizer Investigational Site	Saint Cloud	Florida
United States	Pfizer Investigational Site	Saint George	Utah
United States	Pfizer Investigational Site	Saint Joseph	Michigan
United States	Pfizer Investigational Site	Saint Louis	Missouri
United States	Pfizer Investigational Site	Saint Louis	Missouri
United States	Pfizer Investigational Site	Saint Peters	Missouri
United States	Pfizer Investigational Site	Saint Petersburg	Florida
United States	Pfizer Investigational Site	Saint Petersburg	Florida
United States	Pfizer Investigational Site	Salamanca	New York
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	San Jose	California
United States	Pfizer Investigational Site	San Leandro	California
United States	Pfizer Investigational Site	San Marcos	Texas
United States	Pfizer Investigational Site	Sandersville	Georgia
United States	Pfizer Investigational Site	Santa Ana	California
United States	Pfizer Investigational Site	Santa Ana	California
United States	Pfizer Investigational Site	Santa Maria	California
United States	Pfizer Investigational Site	Sarasota	Florida
United States	Pfizer Investigational Site	Savannah	Georgia
United States	Pfizer Investigational Site	Scottsdale	Arizona
United States	Pfizer Investigational Site	Scranton	Pennsylvania
United States	Pfizer Investigational Site	Sebastian	Florida
United States	Pfizer Investigational Site	Seguin	Texas
United States	Pfizer Investigational Site	Selah	Washington
United States	Pfizer Investigational Site	Shaker Heights	Ohio
United States	Pfizer Investigational Site	Shawnee Mission	Kansas
United States	Pfizer Investigational Site	Shelby	North Carolina
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	Sierra Vista	Arizona
United States	Pfizer Investigational Site	Silver Spring	Maryland
United States	Pfizer Investigational Site	Simpsonville	South Carolina
United States	Pfizer Investigational Site	Smyrna	Delaware
United States	Pfizer Investigational Site	Snellville	Georgia
United States	Pfizer Investigational Site	South Bend	Indiana
United States	Pfizer Investigational Site	South Bend	Indiana
United States	Pfizer Investigational Site	South Bound Brook	New Jersey
United States	Pfizer Investigational Site	South Miami	Florida
United States	Pfizer Investigational Site	Southfield	Michigan
United States	Pfizer Investigational Site	Southfield	Michigan
United States	Pfizer Investigational Site	Southgate	Michigan
United States	Pfizer Investigational Site	Southlake	Texas
United States	Pfizer Investigational Site	Spartanburg	South Carolina
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	Spring	Texas
United States	Pfizer Investigational Site	Springfield	Missouri
United States	Pfizer Investigational Site	Springfield	Tennessee
United States	Pfizer Investigational Site	Statesville	North Carolina
United States	Pfizer Investigational Site	Stephenville	Texas
United States	Pfizer Investigational Site	Sterling Heights	Michigan
United States	Pfizer Investigational Site	Stillwater	Oklahoma
United States	Pfizer Investigational Site	Stockbridge	Georgia
United States	Pfizer Investigational Site	Sturgis	Michigan
United States	Pfizer Investigational Site	Sugar Land	Texas
United States	Pfizer Investigational Site	Sugar Land	Texas
United States	Pfizer Investigational Site	Sulphur Springs	Texas
United States	Pfizer Investigational Site	Sumrall	Mississippi
United States	Pfizer Investigational Site	Sun Lakes	Arizona
United States	Pfizer Investigational Site	Syracuse	New York
United States	Pfizer Investigational Site	Tabor City	North Carolina
United States	Pfizer Investigational Site	Tacoma	Washington
United States	Pfizer Investigational Site	Tallahassee	Florida
United States	Pfizer Investigational Site	Tallassee	Alabama
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Tarzana	California
United States	Pfizer Investigational Site	Taunton	Massachusetts
United States	Pfizer Investigational Site	Taylors	South Carolina
United States	Pfizer Investigational Site	Tempe	Arizona
United States	Pfizer Investigational Site	Tempe	Arizona
United States	Pfizer Investigational Site	The Woodlands	Texas
United States	Pfizer Investigational Site	Thorndale	Pennsylvania
United States	Pfizer Investigational Site	Tipton	Pennsylvania
United States	Pfizer Investigational Site	Toledo	Ohio
United States	Pfizer Investigational Site	Toledo	Ohio
United States	Pfizer Investigational Site	Tomball	Texas
United States	Pfizer Investigational Site	Tomball	Texas
United States	Pfizer Investigational Site	Tonawanda	New York
United States	Pfizer Investigational Site	Topeka	Kansas
United States	Pfizer Investigational Site	Torrance	California
United States	Pfizer Investigational Site	Towson	Maryland
United States	Pfizer Investigational Site	Traverse City	Michigan
United States	Pfizer Investigational Site	Trenton	Ohio
United States	Pfizer Investigational Site	Troy	Michigan
United States	Pfizer Investigational Site	Troy	Michigan
United States	Pfizer Investigational Site	Tucson	Arizona
United States	Pfizer Investigational Site	Tucson	Arizona
United States	Pfizer Investigational Site	Tulare	California
United States	Pfizer Investigational Site	Tulsa	Oklahoma
United States	Pfizer Investigational Site	Union	South Carolina
United States	Pfizer Investigational Site	Uniontown	Pennsylvania
United States	Pfizer Investigational Site	Upland	California
United States	Pfizer Investigational Site	Upper Saint Clair	Pennsylvania
United States	Pfizer Investigational Site	Van Nuys	California
United States	Pfizer Investigational Site	Vero Beach	Florida
United States	Pfizer Investigational Site	Victorville	California
United States	Pfizer Investigational Site	Victorville	California
United States	Pfizer Investigational Site	Vienna	Virginia
United States	Pfizer Investigational Site	Virginia Beach	Virginia
United States	Pfizer Investigational Site	Voorhees	New Jersey
United States	Pfizer Investigational Site	Wabash	Indiana
United States	Pfizer Investigational Site	Waco	Texas
United States	Pfizer Investigational Site	Wadsworth	Ohio
United States	Pfizer Investigational Site	Walla Walla	Washington
United States	Pfizer Investigational Site	Wantagh	New York
United States	Pfizer Investigational Site	Warren	Ohio
United States	Pfizer Investigational Site	Warsaw	New York
United States	Pfizer Investigational Site	Warwick	Rhode Island
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	Waterloo	Iowa
United States	Pfizer Investigational Site	Watkinsville	Georgia
United States	Pfizer Investigational Site	Watseka	Illinois
United States	Pfizer Investigational Site	Waycross	Georgia
United States	Pfizer Investigational Site	Webster	Texas
United States	Pfizer Investigational Site	Wellington	Florida
United States	Pfizer Investigational Site	Wellington	Kansas
United States	Pfizer Investigational Site	West Babylon	New York
United States	Pfizer Investigational Site	West Branch	Michigan
United States	Pfizer Investigational Site	West Burlington	Iowa
United States	Pfizer Investigational Site	West Covina	California
United States	Pfizer Investigational Site	West Jordan	Utah
United States	Pfizer Investigational Site	Westlake	Ohio
United States	Pfizer Investigational Site	Westminster	California
United States	Pfizer Investigational Site	Wexford	Pennsylvania
United States	Pfizer Investigational Site	Wheaton	Maryland
United States	Pfizer Investigational Site	Whitehouse Station	New Jersey
United States	Pfizer Investigational Site	Whittier	California
United States	Pfizer Investigational Site	Wichita	Kansas
United States	Pfizer Investigational Site	Wichita	Kansas
United States	Pfizer Investigational Site	Wichita Falls	Texas
United States	Pfizer Investigational Site	Wildomar	California
United States	Pfizer Investigational Site	Wildwood Crest	New Jersey
United States	Pfizer Investigational Site	Williamsville	New York
United States	Pfizer Investigational Site	Willoughby Hills	Ohio
United States	Pfizer Investigational Site	Wilmington	Delaware
United States	Pfizer Investigational Site	Wilmington	California
United States	Pfizer Investigational Site	Winston-Salem	North Carolina
United States	Pfizer Investigational Site	Woodland Hills	California
United States	Pfizer Investigational Site	Wooster	Ohio
United States	Pfizer Investigational Site	Ypsilanti	Michigan
United States	Pfizer Investigational Site	Yukon	Oklahoma
United States	Pfizer Investigational Site	Zanesville	Ohio
United States	Pfizer Investigational Site	Zionsville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants With Positive Blood Fecal Occult	Positive blood fecal occult; blood in feces that is not visibly apparent	Week 24 or ET
Other	Percentage of Participants With Proton Pump Inhibitor (PPI) and Other Gastric Protective Drug Utilization	PPI and other gastric protective drug (defined as Histamine-2 receptor antagonists [H2RA], misoprostol, sucralfate, and others such as antacids) utilization.	Baseline through week 24 or ET
Other	Percentage of Participants With Non-study Medication Utilization	Non-study medication utilization associated with initial treatment defined as narcotic analgesics and acetaminophen use.	Baseline through week 24 or ET
Primary	Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)	CSULGIE defined as any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; acute gastrointestinal (GI) hemorrhage of unknown origin; small bowel obstruction; clinically significant anemia/blood loss of defined GI origin or presumed occult GI origin.	Baseline through week 24 or Early Termination (ET)
Secondary	Percentage of Participants With Moderate to Severe Abdominal Symptoms	Abdominal symptoms coded using the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) 'Gastrointestinal Disorders' high level group term (HLGT) equal to "Gastrointestinal Signs and Symptoms"; where moderate indicated the gastrointestinal adverse event (GI AE) interfered to some extent with the participants' usual function and severe indicated the GI AE interfered significantly with participants' usual function.	Baseline through week 24 or ET
Secondary	Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs)	GI AEs defined using MedDRA SOC 'Gastrointestinal Disorders' but excluding HLGT's: Benign Neoplasms Gastrointestinal, Dental and Gingival Conditions, Oral Soft Tissue Conditions, Salivary Gland Conditions and Tongue Conditions	Baseline through week 24 or ET
Secondary	Hemoglobin (Hb) at Baseline		Baseline
Secondary	Change From Baseline Hb at Week 24		Baseline and Week 24 or ET
Secondary	Hematocrit (Hct) at Baseline		Baseline
Secondary	Change From Baseline Hct at Week 24		Baseline and Week 24 or ET
Secondary	Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline	Clinically significant decrease in Hct (greater than or equal to 10 percent [=10%]) and/or decrease in Hb (= 2 g/dL).	Baseline, Weeks 8, 16, 24 or ET
Secondary	Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall	Percentage of participants who reported Very Satisfied or Satisfied with current pain medication question on the Patient Treatment Satisfaction Scale (PTSS), scale ranged from Very Satisfied (1) to Very Dissatisfied (5).	Baseline, Weeks 8, 16, 24 or ET
Secondary	Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief	Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the time it took medication to work, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.	Baseline, Weeks 8, 16, 24 or ET
Secondary	Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief	Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy subscale for the amount of pain relief medication provided, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.	Baseline, Weeks 8, 16, 24 or ET
Secondary	Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief	Percentage of participants who reported Very Satisfied or Satisfied with efficacy of current pain medication questions on the PTSS Efficacy, subscale for duration of pain relief provided by medication, scale ranged from Very Satisfied (1) to Very Dissatisfied (5). Possible range of scores 1 to 15.	Baseline, Weeks 8, 16, 24 or ET

External Links

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