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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bausch Health Americas, Inc.
- Enrollment
- 804
- Locations
- 2
- Primary Endpoint
- Average Percentage of Dosing Days That Resulted in Rescue-Free Bowel Movements (RFBMs) Within 4 Hours of Dosing During Weeks 1 to 4
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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..
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.
Arms & Interventions
MNTX 150 mg
Participants will receive methylnaltrexone (MNTX) 150 milligrams (mg) (1 tablet of MNTX 150 mg and 2 matching placebo tablets) orally once daily (QD) for 28 days (4 weeks), then MNTX tablets at a dose as needed (PRN) for remaining 56 days (8 weeks).
Intervention: Methylnaltrexone (Drug)
MNTX 150 mg
Participants will receive methylnaltrexone (MNTX) 150 milligrams (mg) (1 tablet of MNTX 150 mg and 2 matching placebo tablets) orally once daily (QD) for 28 days (4 weeks), then MNTX tablets at a dose as needed (PRN) for remaining 56 days (8 weeks).
Intervention: Placebo (Drug)
MNTX 300 mg
Participants will receive MNTX 300 mg (2 tablets of MNTX 150 mg each and 1 matching placebo tablet) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks).
Intervention: Methylnaltrexone (Drug)
MNTX 300 mg
Participants will receive MNTX 300 mg (2 tablets of MNTX 150 mg each and 1 matching placebo tablet) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks).
Intervention: Placebo (Drug)
MNTX 450 mg
Participants will receive MNTX 450 mg (3 tablets of MNTX 150 mg each) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks).
Intervention: Methylnaltrexone (Drug)
Placebo
Participants will receive 3 tablets of placebo matched to MNTX orally QD for 84 days (12 weeks).
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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
- Percentage of Participants Who Responded (Responder) to Study Drug During Weeks 1 to 4(Weeks 1 to 4)
- Change in Weekly Number of RFBMs From Baseline Over the Entire First 4 Weeks (28 Days) of Dosing(Baseline, Weeks 1 to 4)