Alvimopan For The Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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.