Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication
|ClinicalTrials.gov Identifier: NCT00101998|
Recruitment Status : Completed
First Posted : January 19, 2005
Last Update Posted : August 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Constipation Bowel Dysfunction||Drug: alvimopan Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||233 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects|
|Actual Study Start Date :||October 1, 2003|
|Actual Primary Completion Date :||May 1, 2006|
|Actual Study Completion Date :||May 1, 2006|
Experimental: Alvimopan 0.5 mg Twice Daily (BID)
0.5 milligrams (mg) of alvimopan was administered orally BID for 3 weeks.
Experimental: Alvimopan 1 mg Once Daily (QD)
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.
|Drug: alvimopan Drug: placebo|
Experimental: Alvimopan 1 mg Twice Daily (BID)
0.5 mg of alvimopan was administered orally BID for 3 days, then 1 mg of alvimopan BID for the remaining 3 weeks.
Placebo Comparator: Placebo
Placebo was administered orally BID for 3 weeks.
- 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.
- Additional measures of Bowel movement (BM) frequency and symptoms, safety profile of the treatment regimens and any changes in pain intensity or opioid use.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00101998
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|Study Director:||GSK Clinical Trials, MD||GlaxoSmithKline|