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

NCT ID: NCT00804141

Last Updated: 2019-10-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1040 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-03

Study Completion Date

2010-09-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Constipation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MOA-728 12 mg QD

Participants will receive MOA-728 12 milligrams (mg) SC once daily (QD) for 48 weeks. Dosing could be adjusted to an as needed (PRN) basis with a minimum 1 dose per week and maximum 1 dose per day.

Group Type EXPERIMENTAL

N-methylnaltrexone bromide (MOA-728)

Intervention Type DRUG

MOA-728 will be administered as per the dose and schedule specified in the arm.

Interventions

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N-methylnaltrexone bromide (MOA-728)

MOA-728 will be administered as per the dose and schedule specified in the arm.

Intervention Type DRUG

Other Intervention Names

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Relistor

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lindsey Mathew

Role: STUDY_DIRECTOR

Bausch Health Americas, Inc.

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

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Chandler, Arizona, United States

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Mesa, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tempe, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Hot Springs, Arkansas, United States

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Garden Grove, California, United States

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Laguna Hills, California, United States

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Los Gatos, California, United States

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Newport Beach, California, United States

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Newport Beach, California, United States

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Colorado Springs, Colorado, United States

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Boca Raton, Florida, United States

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Brandon, Florida, United States

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Chiefland, Florida, United States

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Clearwater, Florida, United States

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Daytona Beach, Florida, United States

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Fort Myers, Florida, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jupiter, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Ocala, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Ormond Beach, Florida, United States

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Port Orange, Florida, United States

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Sarasota, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Vero Beach, Florida, United States

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Winter Park, Florida, United States

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Chicago, Illinois, United States

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Rockford, Illinois, United States

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Avon, Indiana, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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West Des Moines, Iowa, United States

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Madisonville, Kentucky, United States

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Hagerstown, Maryland, United States

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Hollywood, Maryland, United States

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Boston, Massachusetts, United States

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Brockton, Massachusetts, United States

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Watertown, Massachusetts, United States

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Bingham Farms, Michigan, United States

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Chesterfield, Michigan, United States

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Kalamazoo, Michigan, United States

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Traverse City, Michigan, United States

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Edina, Minnesota, United States

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Biloxi, Mississippi, United States

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Jackson, Mississippi, United States

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Springfield, Missouri, United States

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Omaha, Nebraska, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Elizabeth, New Jersey, United States

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Albuquerque, New Mexico, United States

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Great Neck, New York, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Fargo, North Dakota, United States

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Centerville, Ohio, United States

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Dayton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Altoona, Pennsylvania, United States

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Levittown, Pennsylvania, United States

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Yardley, Pennsylvania, United States

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Cranston, Rhode Island, United States

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Huntingdon, Tennessee, United States

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Austin, Texas, United States

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Beaumont, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Hurst, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Christiansburg, Virginia, United States

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Bellevue, Washington, United States

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Broadmeadow, New South Wales, Australia

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Edmonton, Alberta, Canada

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Kelowna, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Mount Pearl, Newfoundland and Labrador, Canada

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Dartmouth, Nova Scotia, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Oshawa, Ontario, Canada

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Sarnia, Ontario, Canada

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Toronto, Ontario, Canada

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Mirabel, Quebec, Canada

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Québec, Quebec, Canada

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Saint Romuald, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Barranquilla, Atlántico, Colombia

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Bogota, Cundinamarca, Colombia

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Suwon, Kyonggi-do, South Korea

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Seoul, Seoul/Korea, South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Badalona, Barcelona/Spain, Spain

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Madrid, Madrid/Spain, Spain

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Countries

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United States Australia Canada Colombia South Korea Spain

References

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Michna E, Blonsky ER, Schulman S, Tzanis E, Manley A, Zhang H, Iyer S, Randazzo B. Subcutaneous methylnaltrexone for treatment of opioid-induced constipation in patients with chronic, nonmalignant pain: a randomized controlled study. J Pain. 2011 May;12(5):554-62. doi: 10.1016/j.jpain.2010.11.008. Epub 2011 Mar 22.

Reference Type RESULT
PMID: 21429809 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3200K1-3358&StudyName=Study%20Evaluating%20Long-Term%20Safety%20Of%20MOA-728%20In%20Subjects%20With%20Opioid-Induced%20Constipation

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

Other Identifiers

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3200K1-3358

Identifier Type: -

Identifier Source: org_study_id

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