Study Evaluating Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic Non-Malignant Pain

NCT00529087 | Completed Phase 3 Results

• 1 other identifier: 3200K1-3356
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 78

Brief Summary

The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC).

Conditions

Constipation

Keywords

Opioid-Induced Constipation

Outcome Measures

Primary Outcomes (2)

• Percentage of Patients Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours of the First Dose

  A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS).

  up to 4 hours

• Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 4 Hours of Injection During the Double-blind Period

  A rescue-free bowel movement was defined as a bowel movement where no laxatives were used during the prior 24 hours. Information on laxative use, bowel movements and bowel movement assessments were self reported daily by the patient using a telephone interactive voice response system (IVRS). Active injections are those that contain study drug (e.g., daily injections in MOA-728 QD treatment group and every other injection for the MOA-728 QOD treatment group). The corresponding injections in the placebo group were used as controls.

  4 weeks

Secondary Outcomes (20)

• Time to the First Rescue-free Bowel Movement (RFBM) After First Dose

  up to 24 hours

• Change From Baseline in Weekly Number of Rescue-free Bowel Movements (RFBM) for the Double-blind Period at 4 Weeks

  Baseline and 4 weeks

• Weekly Number of Rescue-free Bowel Movements (RFBM) (Open-label Period)

  8 weeks

• Percentage of Patients Achieving at Least 3 Rescue-free Bowel Movements (RFBM) Per Week in Double-blind Period

  4 weeks

• Percentage of Active Injections Resulting in Any Rescue-free Bowel Movement (RFBM) Within 1, 2, 3 and 6 Hour(s) in Double-blind Period

  Within 1-6 hours during 4 week double-blind period

Study Arms (3)

1

PLACEBO COMPARATOR

Other: placebo

2

EXPERIMENTAL

Drug: N-methylnaltrexone bromide (MOA-728)

3

EXPERIMENTAL

Drug: N-methylnaltrexone bromide (MOA-728)

Interventions

N-methylnaltrexone bromide (MOA-728) DRUG

Subcutaneous

2; 3

placebo OTHER

placebo

1

Eligibility Criteria

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

You may qualify if:

• Adult outpatients with opioid-induced constipation and chronic non-malignant pain.
• Taking oral, transdermal, intravenous, or subcutaneous opioids.
• Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

You may not qualify if:

• History of chronic constipation before the initiation of opioid therapy.
• Other GI disorders known to affect bowel transit.
• Women who are pregnant, breast-feeding, or plan to become pregnant.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead
• Progenics Pharmaceuticals, Inc.: collaborator

Study Sites (78)

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Mobile, Alabama, 36606, United States

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Mobile, Alabama, 36608, United States

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Sun City, Arizona, 85351, 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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Anaheim, California, 92801, United States

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Garden Grove, California, 92843, United States

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Hawaiian Gardens, California, 90716, United States

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Long Beach, California, 90813, United States

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Los Angeles, California, 90048, United States

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San Diego, California, 92121, United States

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Brandon, Florida, 33511, United States

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Cheifland, Florida, 32626, United States

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Clearwater, Florida, 33756, United States

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Gainesville, Florida, 32607, United States

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Jacksonville, Florida, 32216, United States

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Jupiter, Florida, 33458, United States

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Largo, Florida, 33770, United States

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Miami, Florida, 33180, United States

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Naples, Florida, 34104, 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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Spring Hill, Florida, 34609, United States

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Tampa, Florida, 33603, United States

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West Palm Beach, Florida, 33409, United States

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Winter Park, Florida, 32789, United States

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Atlanta, Georgia, 30329, United States

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Marietta, Georgia, 30060, United States

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Stockbridge, Georgia, 30281, United States

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Chicago, Illinois, 60610, United States

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DeKalb, Illinois, 60115, United States

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Avon, Indiana, 46123, 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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Shreveport, Louisiana, 71105, United States

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Sunset, Louisiana, 70584, United States

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Elkridge, Maryland, 21075, United States

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Boston, Massachusetts, 02115, United States

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Brockton, Massachusetts, 02301, United States

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Cadillac, Michigan, 49601, United States

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Paw Paw, Michigan, 49079, United States

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Traverse City, Michigan, 49684, United States

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Biloxi, Mississippi, 39531, United States

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Ocean Springs, Mississippi, 39564, United States

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Nixa, Missouri, 65719, United States

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Kalispell, Montana, 59901, United States

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Missoula, Montana, 59808, United States

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Omaha, Nebraska, 68114, United States

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Las Vegas, Nevada, 89119, 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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Valley Stream, New York, 11580, United States

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Charlotte, North Carolina, 28204, United States

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Raleigh, North Carolina, 27607-6475, United States

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Winston-Salem, North Carolina, 27103, United States

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Dayton, Ohio, 45439, United States

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Toledo, Ohio, 43623, 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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Levittown, Pennsylvania, 19056-2404, United States

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Chattanooga, Tennessee, 37404, United States

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Austin, Texas, 78705, United States

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Beaumont, Texas, 77701, United States

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Colleyville, Texas, 76034, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75251, United States

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San Antonio, Texas, 78209, United States

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San Antonio, Texas, 78229, United States

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Alexandria, Virginia, 22304, United States

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Christiansburg, Virginia, 24073, United States

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Hampton, Virginia, 23666, United States

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Spokane, Washington, 99204, United States

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Spokane, Washington, 99208, United States

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Charleston, West Virginia, 25304-1965, United States

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Related Publications (2)

• Liao SS, Slatkin NE, Stambler N. The Influence of Age on Central Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation. Drugs Aging. 2021 Jun;38(6):503-511. doi: 10.1007/s40266-021-00850-w. Epub 2021 Mar 31.

  PMID: 33788162 DERIVED

• Michna E, Weil AJ, Duerden M, Schulman S, Wang W, Tzanis E, Zhang H, Yu D, Manley A, Randazzo B. Efficacy of subcutaneous methylnaltrexone in the treatment of opioid-induced constipation: a responder post hoc analysis. Pain Med. 2011 Aug;12(8):1223-30. doi: 10.1111/j.1526-4637.2011.01189.x. Epub 2011 Aug 2.

  PMID: 21810165 DERIVED

MeSH Terms

Conditions

Constipation; Opioid-Induced Constipation

Interventions

methylnaltrexone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: U. S. Contact Center
• Organization: Wyeth

clintrialresults@wyeth.com

Study Officials

• Jeff Cohn

  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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2007
• First Posted: September 14, 2007
• Study Start: August 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 25, 2019
• Results First Posted: May 11, 2010

Record last verified: 2019-11

Locations

US (78)