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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
804
Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.
Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arms.
PRA International
Raleigh, North Carolina, United States
PRA, Intl.
Raleigh, North Carolina, United States
Average Percentage of Dosing Days That Resulted in Rescue-Free Bowel Movements (RFBMs) Within 4 Hours of Dosing During Weeks 1 to 4
RFBM was defined as a bowel movement without laxative use within 24 hours prior to bowel movement.
Time frame: Weeks 1 to 4
Percentage of Participants Who Responded (Responder) to Study Drug During Weeks 1 to 4
A responder was defined as at least 3 RFBMs/week, with an increase of at least 1 RFBM/week over baseline, for at least 3 out of the first 4 weeks of the treatment period. Weekly number of RFBMs were calculated as follows: 7 \* total number of RFBMs in a week/all non-missing assessment days in the given week. Weekly number of RFBMs was set to missing for any week when a participant completed less than (\<) 4 diary days in a week. A RFBM was a bowel movement without laxative use within 24 hrs prior to the bowel movement.
Time frame: Weeks 1 to 4
Change in Weekly Number of RFBMs From Baseline Over the Entire First 4 Weeks (28 Days) of Dosing
Weekly number of RFBMs were calculated as follows: 7 \* total number of RFBMs in a week/all non-missing assessment days in the given week. Weekly number of RFBMs was set to missing for any week when a participant completed less than (\<) 4 diary days in a week. A RFBM was a bowel movement without laxative use within 24 hrs prior to the bowel movement.
Time frame: Baseline, Weeks 1 to 4
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