Conditions: Opioid-Induced Constipation
Keywords: Treatment of Opioid-Induced Constipation in Participants with Chronic, Non-Malignant Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 804
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: 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). arm 2: 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). arm 3: 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). arm 4: Participants will receive 3 tablets of placebo matched to MNTX orally QD for 84 days (12 weeks).

Interventions: intervention 1: Methylnaltrexone intervention 2: Placebo
Intervention descriptions: intervention 1: Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms. intervention 2: Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arms.

Protocol document: