Clinical trial NCT01186770: A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid-Induced Constipation
Keywords: Treatment of Opioid-Induced Constipation in Participants with Chronic, Non-Malignant Pain
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Progenics Pharmaceuticals, Inc.
First posted: 2010-08-23
Enrollment: 804
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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:

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.

Primary outcomes:
measure: Average Percentage of Dosing Days That Resulted in Rescue-Free Bowel Movements (RFBMs) Within 4 Hours of Dosing During Weeks 1 to 4
timeFrame: Weeks 1 to 4
Secondary outcomes:
measure: Percentage of Participants Who Responded (Responder) to Study Drug During Weeks 1 to 4
timeFrame: Weeks 1 to 4
measure: Change in Weekly Number of RFBMs From Baseline Over the Entire First 4 Weeks (28 Days) of Dosing
timeFrame: Baseline, Weeks 1 to 4
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: PRA International
state: North Carolina
city: Raleigh
country: United States
facility: PRA, Intl.
state: North Carolina
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Lindsey Mathew
role: STUDY_DIRECTOR
References:
citation: 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.