Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use"

Osteoarthritis, Knee Clinical Trial

Official title:

Double-Blind Parallel-Group Randomized Study Of Efficacy And Safety Of "Continuous Use" Of Celecoxib Vs. The "Usual Use" Of Celecoxib In The Treatment Of Subjects With Chronic Osteoarthritis Of The Hip Or Knee Who Require an Anti-inflammatory Medication for Control Of Their Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139776
• Other study ID #: A3191173
• Status: Completed
• Phase: Phase 4
• Start date: July 2005
• Est. completion date: February 2008

Study information

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

Clinical Trial Summary

To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee and hip.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 875
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subject has been diagnosed, according to American College of Rheumatology guidelines, with osteoarthritis of the hip or knee and requires non-steroidal anti-inflammatory drugs (NSAIDs) to control their osteoarthritis pain and have access to a touch-tone telephone.

Exclusion Criteria:

• Subject has had surgery on index joint.

• Subject has history of rheumatoid arthritis or fibromyalgia syndrome.

• Subject has active gastrointestinal or cardiovascular disease.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

Drug:
• Celecoxib
24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind celecoxib 200 mg daily. Placebo used as flare medication when directed.
• Celecoxib
24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind placebo daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Ham
Belgium	Pfizer Investigational Site	Liege
Brazil	Pfizer Investigational Site	Campinas	SP
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	São Paulo	SP
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Charlottetown	Prince Edward Island
Canada	Pfizer Investigational Site	Corunna	Ontario
Canada	Pfizer Investigational Site	Hamilton	Ontario
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Mirabel	Quebec
Canada	Pfizer Investigational Site	Montague	Prince Edward Island
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Newmarket	Ontario
Canada	Pfizer Investigational Site	North York	Ontario
Canada	Pfizer Investigational Site	Rimouski	Quebec
Canada	Pfizer Investigational Site	Sarnia	Ontario
Canada	Pfizer Investigational Site	Saskatoon	Saskatchewan
Canada	Pfizer Investigational Site	Sherbrooke	Quebec
Canada	Pfizer Investigational Site	St. John's	Newfoundland and Labrador
Canada	Pfizer Investigational Site	St. John's	Newfoundland and Labrador
Canada	Pfizer Investigational Site	St. John's	Newfoundland and Labrador
Canada	Pfizer Investigational Site	Ste-Foy	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Canada	Pfizer Investigational Site	Windsor	Ontario
Chile	Pfizer Investigational Site	Rancagua	VI Región
Chile	Pfizer Investigational Site	Santiago	RM
Chile	Pfizer Investigational Site	Viña Del Mar	V Region
Colombia	Pfizer Investigational Site	Barranquila
Colombia	Pfizer Investigational Site	Bogota
Colombia	Pfizer Investigational Site	Bogota	Cundinamarca
Colombia	Pfizer Investigational Site	Bucaramanga
France	Pfizer Investigational Site	Joue Les Tours
France	Pfizer Investigational Site	L'Union
France	Pfizer Investigational Site	Poitiers
France	Pfizer Investigational Site	Tours
United Kingdom	Pfizer Investigational Site	Bangor
United Kingdom	Pfizer Investigational Site	Barry	Vale Of Glamorgan
United Kingdom	Pfizer Investigational Site	Bath
United Kingdom	Pfizer Investigational Site	Belfast
United Kingdom	Pfizer Investigational Site	Blackpool
United Kingdom	Pfizer Investigational Site	Bradford on Avon	Wiltshire
United Kingdom	Pfizer Investigational Site	Bradwell Common	Milton Keynes
United Kingdom	Pfizer Investigational Site	Canterbury	Kent
United Kingdom	Pfizer Investigational Site	Cardiff
United Kingdom	Pfizer Investigational Site	Cookstown
United Kingdom	Pfizer Investigational Site	Greenisland, Carrickfergus	Northern Ireland
United Kingdom	Pfizer Investigational Site	Leslie	Fife
United Kingdom	Pfizer Investigational Site	Midsomer Norton	Wiltshire
United Kingdom	Pfizer Investigational Site	Newtownabbey	Co.Antrim
United Kingdom	Pfizer Investigational Site	Pound Hill, Crawley	West Sussex
United Kingdom	Pfizer Investigational Site	Randalstown	Co Antrim
United Kingdom	Pfizer Investigational Site	Trowbridge
United Kingdom	Pfizer Investigational Site	Watford	Herts
United Kingdom	Pfizer Investigational Site	Wigan	Lancs
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	Arlington	Virginia
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Beaver	Pennsylvania
United States	Pfizer Investigational Site	Brockton	Massachusetts
United States	Pfizer Investigational Site	Camp Hill	Pennsylvania
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Clinton	Maryland
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Danbury	Connecticut
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Dubuque	Iowa
United States	Pfizer Investigational Site	Dubuque	Iowa
United States	Pfizer Investigational Site	Duncansville	Pennsylvania
United States	Pfizer Investigational Site	Eugene	Oregon
United States	Pfizer Investigational Site	Frederick	Maryland
United States	Pfizer Investigational Site	Great Neck	New York
United States	Pfizer Investigational Site	Greenbelt	Maryland
United States	Pfizer Investigational Site	Huntington Beach	California
United States	Pfizer Investigational Site	Huntsville	Alabama
United States	Pfizer Investigational Site	Jefferson City	Missouri
United States	Pfizer Investigational Site	Jefferson City	Missouri
United States	Pfizer Investigational Site	Johnson City	Tennessee
United States	Pfizer Investigational Site	Johnstown	Pennsylvania
United States	Pfizer Investigational Site	Knoxville	Tennessee
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Long Beach	California
United States	Pfizer Investigational Site	Madisonville	Kentucky
United States	Pfizer Investigational Site	Manlius	New York
United States	Pfizer Investigational Site	Milwaukee	Wisconsin
United States	Pfizer Investigational Site	Mineola	New York
United States	Pfizer Investigational Site	New Milford	Connecticut
United States	Pfizer Investigational Site	New Tazewell	Tennessee
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Ocala	Florida
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Orange	California
United States	Pfizer Investigational Site	Palm Harbor	Florida
United States	Pfizer Investigational Site	Paramount	California
United States	Pfizer Investigational Site	Peoria	Arizona
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Renton	Washington
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	South Miami	Florida
United States	Pfizer Investigational Site	Springfield	Illinois
United States	Pfizer Investigational Site	Springfield	Missouri
United States	Pfizer Investigational Site	Stockton	California
United States	Pfizer Investigational Site	Tacoma	Washington
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Tustin	California
United States	Pfizer Investigational Site	Walnut Creek	California
United States	Pfizer Investigational Site	Waterbury	Connecticut
United States	Pfizer Investigational Site	Wheat Ridge	Colorado
United States	Pfizer Investigational Site	Wheaton	Maryland
United States	Pfizer Investigational Site	Whittier	California
United States	Pfizer Investigational Site	Winston-Salem	North Carolina
United States	Pfizer Investigational Site	Winston-Salem	North Carolina
United States	Pfizer Investigational Site	Yakima	Washington
United States	Pfizer Investigational Site	Yakima	Washington
United States	Pfizer Investigational Site	Zanesville	Ohio
United States	Pfizer Investigational Site	Zephyrhills	Florida

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Canada,  Chile,  Colombia,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Medical Outcomes Study Sleep Scale - All Assessments	Subject assessment on 7 sleep associated categories. Raw scores are transformed to a 0-100 scale. Higher score indicates more of the outcome (e.g. more snoring, more adequate sleep). Score at end of Period III minus score at start of Period III.	Period III
Other	Medical Outcomes Study Sleep Scale - Number of Participants With Optimal, Mixed and Not Optimal Sleep	Transformed score scale: 1=optimal; 0=not optimal; mixed = both optimal and non-optimal sleep during Period III	Period III
Other	Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments	SF-12v2 is a 12 item health survey covering 7 topics. Raw scores are transformed to a 0 to 100 scale. Higher scores indicate better state of health. Score at end of Period III minus score at start of Period III.	Period III
Other	Serious Adverse Events in Open Label run-in Period	Serious adverse events occuring during the 2 week run-in period (Period II) when all participants were dosed with celecoxib 200 mg daily	2 weeks prior to double blind dosing
Primary	Number of Flare Events Per Time of Exposure to Study Medication	Number of flare events per month during Period III (calculated as number of flares divided by number of months participant was enrolled during Period III). Flare was determined using pre-defined criteria, using an interactive voice response system.	Period III (22 weeks)
Secondary	Time to Occurrence of First Osteoarthritis (OA) Flare	Time from first dose of double blind medication (start of Period III) to occurrence of first OA flare. Flare was determined using pre-defined criteria, using an interactive voice response system	Period III (22 weeks)
Secondary	Proportion of Days Free From Osteoarthritis (OA) Flare	Number of days subject was free from OA flare divided by number of days on study medication in Period III. Flare was determined using pre-defined criteria, using an interactive voice response system.	Period III (22 weeks)
Secondary	Proportion of Days in Osteoarthritis (OA) Flare	Number of days subject was in OA flare divided by number of days on study medication in Period III. Subjects may have more than one flare. Flare was determined using pre-defined criteria, using an interactive voice response system.	Period III (22 weeks)
Secondary	Arthritis Pain Numerical Rating Scale (NRS)	Participant rated intensity of osteoarthritis pain on categorical scale from 0 (no pain) to 10 (worst pain). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III.	Period III
Secondary	Patient's Global Assessment of Arthritis	Participant's response to question "Considering all the ways the osteoarthritis in your hip or knee affects you, how are you doing today?" on scale from 1 (very good) to 5 (very poor). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III.	Period III
Secondary	Physician's Global Assessment of Arthritis at Final Visit	Physician assessed each participant's disease symptoms on a categorical scale from 1 (very good) to 5 (very poor).	Period III (22 weeks)
Secondary	Total Rescue Medication Taken (Mean)	Total amount of rescue medication (acetaminophen in milligrams [mg]) taken per month per participant	Period III (22 weeks)
Secondary	Proportion of Days on Rescue Medication	Days on rescue medication divided by number of days on study medication in Period III	Period III (22 weeks)
Secondary	Days on Flare Medication	Number of days on flare medication per month per subject calculated as number of days on flare medication divided by the number of days on study medication in Period III	Period III (22 weeks)
Secondary	Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores	Score at end of Period III minus score at start of Period III. WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Negative change indicates improvement.	Period III (22 weeks)
Secondary	Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores	WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Scores analyzed as area under the curve (AUC) of participant's WOMAC scores from each assessment in Period III.	Period III (22 weeks)

External Links

•   To obtain contact information for a study center near you, click here.