Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication

Phase 2

Completed

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

• Registration Number: NCT00101998
• Lead Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Brief Summary

A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. The study will require five visits over a five-week period.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10-01
• Study First Submitted: 2005-01-18
• Study First Submitted QC: 2005-01-18
• Study First Posted: 2005-01-19
• Primary Completion: 2006-05-01
• Study Completion: 2006-05-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Placebo was administered orally BID for 3 weeks.
Alvimopan 1 mg Once Daily (QD)	placebo	0.5 mg of alvimopan was administered orally QD for 3 days, then 1 mg of alvimopan QD for the remaining 3 weeks. Placebo was administered orally QD to maintain the blind. A protocol amendment dropped this arm because another study had demonstrated 1 mg QD treatment to have similar efficacy but a less favorable gastrointestinal-related safety profile compared with 0.5 mg BID treatment.
Alvimopan 0.5 mg Twice Daily (BID)	alvimopan	0.5 milligrams (mg) of alvimopan was administered orally BID for 3 weeks.
Alvimopan 1 mg Once Daily (QD)	alvimopan	0.5 mg of alvimopan was administered orally QD for 3 days, then 1 mg of alvimopan QD for the remaining 3 weeks. Placebo was administered orally QD to maintain the blind. A protocol amendment dropped this arm because another study had demonstrated 1 mg QD treatment to have similar efficacy but a less favorable gastrointestinal-related safety profile compared with 0.5 mg BID treatment.
Alvimopan 1 mg Twice Daily (BID)	alvimopan	0.5 mg of alvimopan was administered orally BID for 3 days, then 1 mg of alvimopan BID for the remaining 3 weeks.

Primary Outcome Measures

Name	Time	Method
Change in weekly SCBM frequency. A SCBM is a spontaneous and complete bowel movement, which means a bowel movement that occurs with no laxative use in the prior 24 hours and leaves the subject with the feeling of complete evacuation of the rectum.

Secondary Outcome Measures

Name	Time	Method
Additional measures of Bowel movement (BM) frequency and symptoms, safety profile of the treatment regimens and any changes in pain intensity or opioid use.

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Surrey, United Kingdom