Alvimopan for Bladder Cancer Surgery Recovery

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.
Ready to participate?

Review the details below, then apply to join this clinical trial.

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
Who this trial is looking for

This trial is looking for patients having surgery to remove the bladder and connect the urinary system. Participants will take Alvimopan or a placebo to see if it helps them recover bowel function faster after surgery.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am having a radical cystectomy with urinary diversion.
  • I am between 18 and 85 years old.
  • I have an American Society of Anesthesiologists score of class 1-4.
  • I can understand the study procedures and agree to take part.

You may not be able to join if

  • I am scheduled for a partial cystectomy.
  • I have had a total colectomy, gastrectomy, or gastric bypass.
  • I have taken more than three doses of opioids in the past week.
  • I had chemotherapy for bladder cancer within the last month.
  • I am pregnant, breastfeeding, or not postmenopausal and not using birth control.
  • I have participated in another study in the last 30 days.
  • I have severe dementia or significant liver impairment.
  • I have end-stage renal disease or heart failure.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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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