drugset / Trial / NCT00331045

Clinical Evaluation Of Alvimopan (SB767905) On Constipation And Related Symptoms Associated With Opioid

NCT00331045

Phase 2 Terminated 21 enrolled Merck & Co., Inc. GlaxoSmithKline · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is intended to investigate the recommended dose of alvimopan in doses 0.25mg/day (0.25mg, OD), 0.5mg/day (0.25mg, BID) or 1mg/day (0.5mg, BID) or placebo for 3 weeks in patients who receive opioids for the management of cancer pain and develop constipation, by giving overall consideration to the efficacy and safety data in each treatment group. Also, efficacy and safety data of alvimopan in the recommended dose group will be compared with those of placebo and to confirm alvimopan's safety and efficacy.

Timeline

Start
2006-04
Primary completion
2006-10
Completion
2006-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Alvimopan Small molecule 0.25 mg
Subject Alvimopan Small molecule 0.5 mg
Subject Alvimopan Small molecule 1 mg