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

NCT00804141 | Completed Phase 3 Results

• 1 other identifier: 3200K1-3358
• Study Type: interventional
• Target: 1,040
• Locations: 6 countries
• Sites: 120

Brief 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.

Conditions

Constipation

Keywords

treatment for opioid-induced constipation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in Weekly Bowel Movement (BM) Rate Through Follow-up

  Baseline, follow-up (14 days [Week 49 to 50])

Study Arms (1)

MOA-728 12 mg QD

EXPERIMENTAL

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.

Drug: N-methylnaltrexone bromide (MOA-728)

Interventions

N-methylnaltrexone bromide (MOA-728) DRUG

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

Also known as: Relistor

MOA-728 12 mg QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead
• Pfizer: collaborator

Study Sites (120)

Pfizer Investigational Site

Birmingham, Alabama, 35242, United States

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Chandler, Arizona, 85224, United States

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Mesa, Arizona, 85206, United States

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Mesa, Arizona, 85213, United States

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Phoenix, Arizona, 85028, United States

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Phoenix, Arizona, 85029, United States

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Tempe, Arizona, 85282, United States

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Tucson, Arizona, 85710, United States

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Tucson, Arizona, 85741, United States

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Hot Springs, Arkansas, 71913, United States

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Garden Grove, California, 92843, United States

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Laguna Hills, California, 92653, United States

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Los Gatos, California, 95032, United States

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Newport Beach, California, 92660, United States

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Newport Beach, California, 92663, United States

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Colorado Springs, Colorado, 80904, United States

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Boca Raton, Florida, 33432, United States

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Brandon, Florida, 33511, United States

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Chiefland, Florida, 32626, United States

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Clearwater, Florida, 33756, United States

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Daytona Beach, Florida, 32117, United States

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Fort Myers, Florida, 33916, United States

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Gainesville, Florida, 32607, United States

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Jacksonville, Florida, 32216, United States

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Jacksonville, Florida, 32257, United States

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Jupiter, Florida, 33458, United States

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Miami, Florida, 33180, United States

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Miami, Florida, 33183, United States

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Ocala, Florida, 34471-2106, United States

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Ocala, Florida, 34471, United States

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Ocala, Florida, 34474, United States

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Orlando, Florida, 32806, United States

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Ormond Beach, Florida, 32174, United States

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Port Orange, Florida, 32129, United States

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Sarasota, Florida, 34231, United States

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Sarasota, Florida, 34239, United States

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Tampa, Florida, 33603, United States

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Tampa, Florida, 33613, United States

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Vero Beach, Florida, 32960, United States

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Winter Park, Florida, 32789, United States

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Chicago, Illinois, 60616, United States

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Rockford, Illinois, 61107, United States

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Avon, Indiana, 46123, United States

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Evansville, Indiana, 47714, United States

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Indianapolis, Indiana, 46205, United States

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Indianapolis, Indiana, 46250, United States

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West Des Moines, Iowa, 50265, United States

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Madisonville, Kentucky, 42431, United States

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Hagerstown, Maryland, 21742, United States

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Hollywood, Maryland, 20636, United States

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Boston, Massachusetts, 02115, United States

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Brockton, Massachusetts, 02301, United States

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Watertown, Massachusetts, 02472, United States

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Bingham Farms, Michigan, 48025, United States

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Chesterfield, Michigan, 48047, United States

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Kalamazoo, Michigan, 49009, United States

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Traverse City, Michigan, 49684, United States

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Edina, Minnesota, 55435, United States

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Biloxi, Mississippi, 39531, United States

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Jackson, Mississippi, 39202, United States

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Springfield, Missouri, 65807, United States

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Omaha, Nebraska, 68131, United States

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Henderson, Nevada, 89014, United States

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Las Vegas, Nevada, 89119, United States

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Las Vegas, Nevada, 89123, United States

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Las Vegas, Nevada, 89146, United States

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Elizabeth, New Jersey, 07202, United States

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Albuquerque, New Mexico, 87102, United States

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Great Neck, New York, 11023, United States

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New York, New York, 10022, United States

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Charlotte, North Carolina, 28204, United States

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Raleigh, North Carolina, 27607, United States

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Fargo, North Dakota, 58103, United States

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Centerville, Ohio, 45459, United States

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Dayton, Ohio, 45432, United States

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Oklahoma City, Oklahoma, 73112, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 97210, United States

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Altoona, Pennsylvania, 16602, United States

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Levittown, Pennsylvania, 19056, United States

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Yardley, Pennsylvania, 19067, United States

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Cranston, Rhode Island, 02920, United States

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Huntingdon, Tennessee, 38344, United States

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Austin, Texas, 78705, United States

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Beaumont, Texas, 77701, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75234, United States

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Houston, Texas, 77074, United States

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Hurst, Texas, 76054, United States

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San Antonio, Texas, 78215, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84106, United States

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Christiansburg, Virginia, 24073, United States

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Bellevue, Washington, 98007, United States

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Broadmeadow, New South Wales, 2292, Australia

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Edmonton, Alberta, T5A 4L8, Canada

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Kelowna, British Columbia, V1Y 1Z9, Canada

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Vancouver, British Columbia, V5Z 1K3, Canada

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Winnipeg, Manitoba, R2V 4W3, Canada

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Mount Pearl, Newfoundland and Labrador, A1N 5B6, Canada

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Dartmouth, Nova Scotia, B2Y 1H3, Canada

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Hamilton, Ontario, L8M 1K7, Canada

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London, Ontario, N5Y 5K7, Canada

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Oshawa, Ontario, L1H 7K4, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Mirabel, Quebec, J7J 2K8, Canada

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Québec, Quebec, G2B 5S1, Canada

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Saint Romuald, Quebec, G6W 5M6, Canada

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Sainte-Foy, Quebec, G1W 4R4, Canada

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Sherbrooke, Quebec, J1H 1Z1, Canada

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Trois-Rivières, Quebec, G8T 7A1, Canada

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Barranquilla, Atlántico, Colombia

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Bogota, Cundinamarca, Colombia

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Suwon, Kyonggi-do, 443-721, South Korea

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Seoul, Seoul/Korea, 138-736, South Korea

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Seoul, 120-752, South Korea

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Seoul, 137-701, South Korea

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Badalona, Barcelona/Spain, 08916, Spain

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Madrid, Madrid/Spain, 28006, Spain

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Related Publications (1)

• 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.

  PMID: 21429809 RESULT

Related Links

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

MeSH Terms

Conditions

Constipation

Interventions

methylnaltrexone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Bausch Health Americas, Inc

Lindsey.Mathew@bauschhealth.com

Study Officials

• Lindsey Mathew

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 8, 2008
• Study Start: December 3, 2008
• Primary Completion: September 20, 2010
• Study Completion: September 20, 2010
• Last Updated: October 18, 2019
• Results First Posted: October 18, 2019

Record last verified: 2019-09

Locations

AU (1); CA (17); KR (4); US (94); CO (2); ES (2)