This is an adaptive design study. During the first phase of the study, participants will be randomized in 2:1 ratio to receive either MNTX 450 milligrams (mg) once daily (QD) or placebo. An interim analysis will be performed for futility and at that point a higher dosage regimen may be utilized for the active treatment group if the futility criteria are met. For the second stage of the study, interim analyses will be conducted for futility and sample size reassessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Methylnaltrexone bromide will be administered per dose and schedule specified in the respective arm.
Placebo matching to methylnaltrexone bromide will be administered as mentioned in the respective arm.
Bausch Site 001
Omaha, Nebraska, United States
Overall Survival
Time frame: From randomization until death from any cause (up to Day 168)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.