drugset / Trial / NCT00241722

Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

NCT00241722

Phase 3 Completed 805 enrolled Merck & Co., Inc. GlaxoSmithKline · collab
RandomizedParallel-groupQuadruple-blindTreatment

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) to alvimopan or placebo. The primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment of OBD. Participants will be required to attend 8 clinic visits over approximately 1 year.

Timeline

Start
2005-08-01
Primary completion
2007-02-01
Completion
2007-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Alvimopan Small molecule 0.5 mg Oral

Indications