Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

Phase 3

Completed

• Conditions: Bowel Dysfunction; Constipation
• Interventions: Drug: alvimopan; Drug: Placebo

• Registration Number: NCT00256932
• Lead Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-11-21
• Study First Submitted QC: 2005-11-21
• Study First Posted: 2005-11-22
• Study Completion: 2006-05
• Status Verified: 2011-12
• Last Update Submitted: 2015-09-01
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 518

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alvimopan 0.5 mg once daily	alvimopan	-
Placebo	Placebo	-
alvimopan 0.5 mg twice daily	alvimopan	-

Primary Outcome Measures

Name	Time	Method
to compare alvimopan with placebo for efficacy in the treatment of OBD

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability, quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data)

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 York, United Kingdom