At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 280 enrolled
Drug / intervention
Alvimopan +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 4, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy.
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Jul 2, 2008·Updated Jan 8, 2016
In Brief
A Phase 4 clinical trial evaluating Alvimopan and Placebo for Postoperative Ileus. Completed, enrolled 280 participants across 20 sites.
Detailed Summary
This study is being conducted to determine whether alvimopan can accelerate recovery of gastrointestinal function following radical cystectomy when compared with a placebo. Secondary objectives of the study are: * to evaluate the effect of alvimopan on hospital length of stay * to evaluate the effect of alvimopan on prespecified postoperative ileus (POI)-related morbidities * to evaluate the overall and cardiovascular safety of alvimopan
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Ileus
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2008
Enrollment StartMar 2009
Primary CompletionJan 2012
TodayJul 2026
First PostedJul 2, 2008
Enrollment StartMar 1, 2009
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18 years ago
Interventions
Alvimopandrug
Placebodrug