Overview

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

Status:
Completed
Trial end date:
2011-09-08
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bausch Health Americas, Inc.
Valeant Pharmaceuticals International, Inc.
Collaborator:
Progenics Pharmaceuticals, Inc.
Treatments:
Analgesics, Opioid
Bromides
Methylnaltrexone
Naltrexone
Criteria
Key Inclusion Criteria:

1. 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.

2. Taking oral, transdermal, intravenous (IV), or subcutaneous (SC) opioids for chronic
non-malignant pain for ≥1 month.

3. No known history of chronic constipation prior to the initiation of opioid therapy.

4. 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:

1. Prior treatment with oral MNTX.

2. Prior treatment with SC MNTX within 30 days of screening.

3. Women who are pregnant, breastfeeding, or plan to become pregnant during the study.

4. 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.

5. Current treatment with partial opioid agonists (for example; buprenorphine) or
combination agonists/antagonists.