Phase 3
N=804
A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain
Opioid-Induced Constipation
Bottom Line
View on ClinicalTrials.gov: NCT01186770 ↗Enrolled (actual)
804
Serious AEs
2.9%
Results posted
Sep 2019
Primary outcome: Primary: Average Percentage of Dosing Days That Resulted in Rescue-Free Bowel Movements (RFBMs) Within 4 Hours of Dosing During Weeks 1 to 4 — 21.05; 24.64; 27.40; 18.18 percentage of days — p=0.1692
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Methylnaltrexone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Percentage of Dosing Days That Resulted in Rescue-Free Bowel Movements (RFBMs) Within 4 Hours of Dosing During Weeks 1 to 4 |
21.05; 24.64; 27.40; 18.18 | 0.1692 |
| SECONDARY Percentage of Participants Who Responded (Responder) to Study Drug During Weeks 1 to 4 |
45.3; 51.7; 54.5; 40.8 | 0.3076 |
| SECONDARY Change in Weekly Number of RFBMs From Baseline Over the Entire First 4 Weeks (28 Days) of Dosing |
1.46; 1.35; 1.37; 1.49; 1.98; 2.43 | 0.6920 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01186770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.