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Bladder CancerCancerKidney and urinaryDrugPhase 3

What this study is

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.

What's being tested

  • Alvimopan

    Intervention · DRUG

    To determine if Alvimopan during radical cystectomy with urinary diversion results in faster return of bowel function.

  • Placebo

    Intervention · DRUG

    To determine if placebo during radical cystectomy with urinary diversion results in faster return of bowel function.

Study details

Official title
A Randomized, Double-blind, Single-Center Trial of Alvimopan (Entereg) Versus Placebo in Patients Undergoing Radical Cystectomy and Urinary Diversion on an Enhanced Recovery After Surgery ERAS Protocol
Sponsor
Brigham and Women's Hospital
Conditions
Bladder Cancer
Enrolling
136 people
Starts
2018-10-01
Est. completion
2024-06-01
Design
Double-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗