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

Recruiting Phase 3 Interventional Study
Bladder Cancer
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
136 (estimated)
Sponsor
Brigham and Women's Hospital · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patients undergoing radical cystectomy and urinary diversion via open or robotic approach. * Man or woman between the ages of 18 and 85. * American Society of Anesthesiologists (ASA) Physical Status Score of class 1-4 * Ileal conduit or ileal neobladder urinary diversion * Abl…
Contacts

Martin Barylak

6175258274

mbarylak@bwh.harvard.edu

CONTACT

Anjali Vasavada

6175258274

AVASAVADA@BWH.HARVARD.EDU

CONTACT