Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation

Constipation Clinical Trial

Official title:

An Open-Label Study to Evaluate the Long-Term Safety of Subcutaneous MOA-728 for Treatment of Opioid-Induced Constipation in Subjects With Nonmalignant Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804141
• Other study ID #: 3200K1-3358
• Status: Completed
• Phase: Phase 3
• Start date: December 3, 2008
• Est. completion date: September 20, 2010

Study information

• Verified date: September 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the long-term safety and tolerability of the subcutaneous (SC) injection form of N-methylnaltrexone bromide (MOA-728) for the treatment of opioid-induced constipation in participants with nonmalignant pain. The study consists of a 2-week screening period, a 48-week open-label treatment period and a 2 week follow-up period. Participants will need to agree to self-administer SC injections, complete daily diaries, and check-in via a daily telephone call during the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1040
• Est. completion date: September 20, 2010
• Est. primary completion date: September 20, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women 18 years or older.

• A history of pain of at least 2 months duration before the screening visit due to documented underlying nonmalignant condition.

• A history of constipation due to opioid use during 1 month before the screening visit.

Exclusion Criteria:

• A diagnosis of significant gastrointestinal (GI) disorder such as bowel obstruction, fecal incontinence or rectal prolapse.

• A history of active inflammatory bowel disease, irritable bowel syndrome, or megacolon within 6 months before the screening visit.

• A history of malignancy, other than basal cell or squamous cell skin carcinoma, within 5 years before the screening visit.

• A history of chronic constipation before initiation of opioid therapy.

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• N-methylnaltrexone bromide (MOA-728)
MOA-728 will be administered as per the dose and schedule specified in the arm.

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Broadmeadow	New South Wales
Canada	Pfizer Investigational Site	Dartmouth	Nova Scotia
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Hamilton	Ontario
Canada	Pfizer Investigational Site	Kelowna	British Columbia
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Mirabel	Quebec
Canada	Pfizer Investigational Site	Mount Pearl	Newfoundland and Labrador
Canada	Pfizer Investigational Site	Oshawa	Ontario
Canada	Pfizer Investigational Site	Quebec
Canada	Pfizer Investigational Site	Sainte-Foy	Quebec
Canada	Pfizer Investigational Site	Sarnia	Ontario
Canada	Pfizer Investigational Site	Sherbrooke	Quebec
Canada	Pfizer Investigational Site	St-Romuald	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Trois-Rivieres	Quebec
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Colombia	Pfizer Investigational Site	Barranquilla	Atlantico
Colombia	Pfizer Investigational Site	Bogota	Cundinamarca
Korea, Republic of	Pfizer Investigational Site	Seoul	Seoul/Korea
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Suwon	Kyonggi-do
Spain	Pfizer Investigational Site	Badalona	Barcelona/Spain
Spain	Pfizer Investigational Site	Madrid	Madrid/Spain
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Altoona	Pennsylvania
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Avon	Indiana
United States	Pfizer Investigational Site	Beaumont	Texas
United States	Pfizer Investigational Site	Bellevue	Washington
United States	Pfizer Investigational Site	Biloxi	Mississippi
United States	Pfizer Investigational Site	Bingham Farms	Michigan
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Boca Raton	Florida
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Brandon	Florida
United States	Pfizer Investigational Site	Brockton	Massachusetts
United States	Pfizer Investigational Site	Centerville	Ohio
United States	Pfizer Investigational Site	Chandler	Arizona
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Chesterfield	Michigan
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Chiefland	Florida
United States	Pfizer Investigational Site	Christiansburg	Virginia
United States	Pfizer Investigational Site	Clearwater	Florida
United States	Pfizer Investigational Site	Colorado Springs	Colorado
United States	Pfizer Investigational Site	Cranston	Rhode Island
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dayton	Ohio
United States	Pfizer Investigational Site	Daytona Beach	Florida
United States	Pfizer Investigational Site	Edina	Minnesota
United States	Pfizer Investigational Site	Elizabeth	New Jersey
United States	Pfizer Investigational Site	Evansville	Indiana
United States	Pfizer Investigational Site	Fargo	North Dakota
United States	Pfizer Investigational Site	Fort Myers	Florida
United States	Pfizer Investigational Site	Gainesville	Florida
United States	Pfizer Investigational Site	Garden Grove	California
United States	Pfizer Investigational Site	Great Neck	New York
United States	Pfizer Investigational Site	Hagerstown	Maryland
United States	Pfizer Investigational Site	Henderson	Nevada
United States	Pfizer Investigational Site	Hollywood	Maryland
United States	Pfizer Investigational Site	Hot Springs	Arkansas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Huntingdon	Tennessee
United States	Pfizer Investigational Site	Hurst	Texas
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Jackson	Mississippi
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Jupiter	Florida
United States	Pfizer Investigational Site	Kalamazoo	Michigan
United States	Pfizer Investigational Site	Laguna Hills	California
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Levittown	Pennsylvania
United States	Pfizer Investigational Site	Los Gatos	California
United States	Pfizer Investigational Site	Madisonville	Kentucky
United States	Pfizer Investigational Site	Medford	Oregon
United States	Pfizer Investigational Site	Mesa	Arizona
United States	Pfizer Investigational Site	Mesa	Arizona
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Newport Beach	California
United States	Pfizer Investigational Site	Newport Beach	California
United States	Pfizer Investigational Site	Ocala	Florida
United States	Pfizer Investigational Site	Ocala	Florida
United States	Pfizer Investigational Site	Ocala	Florida
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Ormond Beach	Florida
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Port Orange	Florida
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Rockford	Illinois
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	Sarasota	Florida
United States	Pfizer Investigational Site	Sarasota	Florida
United States	Pfizer Investigational Site	Springfield	Missouri
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Tempe	Arizona
United States	Pfizer Investigational Site	Traverse City	Michigan
United States	Pfizer Investigational Site	Tucson	Arizona
United States	Pfizer Investigational Site	Tucson	Arizona
United States	Pfizer Investigational Site	Vero Beach	Florida
United States	Pfizer Investigational Site	Watertown	Massachusetts
United States	Pfizer Investigational Site	West Des Moines	Iowa
United States	Pfizer Investigational Site	Winter Park	Florida
United States	Pfizer Investigational Site	Yardley	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.	Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Colombia,  Korea, Republic of,  Spain, 

References & Publications (1)

Webster R, Michna E, Khan A, et al., The long-term efficacy of subcutaneous methylnaltrexone for the treatment of opioid-induced constipation in patients with chronic nonmalignant pain. J. Pain, 12(4), Supplement , Page P70, April 2011

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Serious adverse events (SAEs) included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as an AE that emerged during the treatment period. Any TEAEs included both treatment-emergent SAEs and non-serious AEs. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.	Baseline up to Week 50
Secondary	Change From Baseline in Weekly Bowel Movement (BM) Rate Through Follow-up	Weekly BM rate was derived as the total number of BMs reported in a month divided by the total number of days with non-missing BM diary information in the same month, then multiplied by 7 to normalize to a weekly rate. If the total number of days with non-missing BM diary information in a given month was less than 10 days, the weekly BM rate for the month was defined as missing. The weekly BM rate at baseline was calculated based on the screening period (Days -14 to -1). If the total number of days with non-missing BM diary information during the screening period was less than 5 days, the weekly BM rate at baseline was defined as missing.	Baseline, follow-up (14 days [Week 49 to 50])

External Links

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