Clinical Trial

Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol

Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated September 28, 2023 (before its estimated December 1, 2023 completion). Its status may not reflect the trial's current state.
Summary
To determine if Alvimopan during open or robotic radical cystectomy with urinary diversion results in quicker return of bowel function (GI-2 recovery = time to upper \[first toleration of solid food\] and lower \[first bowel movement\] gastrointestinal recovery) compared to placebo.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2017-07-11; most recent amendment 2025-11-04.
Status change: Recruiting → Completed 2025-09-23
Status change: Not Yet Recruiting → Recruiting 2020-01-29
Trial Details
NCT Number NCT03216525
Lead Sponsor Brigham and Women's Hospital
Collaborators: Merck Sharp & Dohme LLC
Conditions Bladder Cancer
Enrollment 136 participants
Start Date 2018-10-01
Primary Completion 2023-12-01 (estimated)
Study Completion 2024-06-01 (estimated)
Updated on ClinicalTrials.gov 2023-09-28