A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain
Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one of 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.
Inclusion criteria:
Exclusion criteria:
Winterhaven, Florida 33880, United States
North York, Ontario M2M 4E7, Canada
Rådahl, 5235, Norway
Athlone, Cape Town, 7760, South Africa
Erasmuskloof, Pretoria, 0048, South Africa
Fourways, Johannesburg, South Africa
Kenilworth, Cape Town, 7708, South Africa
Lynnwood, Pretoria, 0040, South Africa
Tygervalley, 7536, South Africa
Westridge, Mitchells Plain, 7798, South Africa