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

Phase 3

Completed

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

• Registration Number: NCT00241722
• 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) 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-01
• Study First Submitted: 2005-10-17
• Study First Submitted QC: 2005-10-17
• Study First Posted: 2005-10-19
• Primary Completion: 2007-02-01
• Study Completion: 2007-02-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 805

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo was administered orally BID for 12 months.
Alvimopan 0.5 mg Twice Daily (BID)	Alvimopan	0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months.

Primary Outcome Measures

Name	Time	Method
To compare alvimopan with placebo for long-term safety and tolerability	12 months

Secondary Outcome Measures

Name	Time	Method
Quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data)	12 months

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Yaxley, Peterborough, United Kingdom