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Completed

NCT Number: NCT01186770

A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain

MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in participants with chronic, non-malignant pain.

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Key information

Conditions

Opioid-induced Constipation Chemically-Induced Disorders Constipation Mental Disorders Narcotic-Related Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

PRA International, Raleigh, North Carolina, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • History of chronic non-malignant pain (originating from a non-malignant source) with condition(s) underlying the chronic pain of greater than or equal to (≥) 2 months' duration before the screening visit.
  • Taking oral, transdermal, intravenous (IV), or subcutaneous (SC) opioids for chronic non-malignant pain for ≥1 month.
  • No known history of chronic constipation prior to the initiation of opioid therapy.
  • Currently taking laxative therapy for ≥30 days and willing to discontinue all laxative therapy at the start of screening period and use only study-permitted rescue laxatives throughout the screening and double-blind treatment periods..

Key Exclusion Criteria:

  • Prior treatment with oral MNTX.
  • Prior treatment with SC MNTX within 30 days of screening.
  • Women who are pregnant, breastfeeding, or plan to become pregnant during the study.
  • Fecal incontinence, rectal prolapse, fecal ostomy or other clinically significant gastrointestinal disorders such as inflammatory bowel disease or clinically significant irritable bowel syndrome that would have made bowel movement assessment inaccurate.
  • Current treatment with partial opioid agonists (for example; buprenorphine) or combination agonists/antagonists.

Treatment and study plan

methylnaltrexone

Drug

Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.

Other names: Relistor

Placebo

Drug

Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arms.

Primary outcomes

  1. Average Percentage of Dosing Days That Resulted in Rescue-Free Bowel Movements (RFBMs) Within 4 Hours of Dosing During Weeks 1 to 4

    Time frame: Weeks 1 to 4

    RFBM was defined as a bowel movement without laxative use within 24 hours prior to bowel movement.

Secondary outcomes

  1. Percentage of Participants Who Responded (Responder) to Study Drug During Weeks 1 to 4

    Time frame: Weeks 1 to 4

    A responder was defined as at least 3 RFBMs/week, with an increase of at least 1 RFBM/week over baseline, for at least 3 out of the first 4 weeks of the treatment period. Weekly number of RFBMs were calculated as follows: 7 * total number of RFBMs in a week/all non-missing assessment days in the given week. Weekly number of RFBMs was set to missing for any week when a participant completed less than (<) 4 diary days in a week. A RFBM was a bowel movement without laxative use within 24 hrs prior to the bowel movement.

  2. Change in Weekly Number of RFBMs From Baseline Over the Entire First 4 Weeks (28 Days) of Dosing

    Time frame: Baseline, Weeks 1 to 4

    Weekly number of RFBMs were calculated as follows: 7 * total number of RFBMs in a week/all non-missing assessment days in the given week. Weekly number of RFBMs was set to missing for any week when a participant completed less than (<) 4 diary days in a week. A RFBM was a bowel movement without laxative use within 24 hrs prior to the bowel movement.

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Collaborators

  • Progenics Pharmaceuticals, Inc.

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Oral Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Chronic, Non-Malignant Pain

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 23, 2010
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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