NCT00331045

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

Clinical Evaluation of Alvimopan (SB767905) on Constipation and Related Symptoms Associated With Opioid -A Placebo-controlled Double-blind Study in Cancer Patients-

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Constipation

Interventions

Type	Name	Description
DRUG	alvimopan	0.25 mg/day
DRUG	Placebo
DRUG	Alvimopan 0.5 mg/day
DRUG	Alvimopan 1 mg/day

Timeline

• Start date: 2006-04-01
• Primary completion: 2006-10-01
• Completion: 2006-12-01
• First posted: 2006-05-29
• Last updated: 2015-09-02