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Alvimopan for Faster Bowel Recovery After Bladder Cancer Surgery

This study is looking at whether a drug called Alvimopan can help people recover bowel function more quickly after surgery for bladder cancer. This surgery, called a radical cystectomy, removes the bladder and creates a new way for urine to leave the body (urinary diversion). Researchers want to see if Alvimopan helps you start eating solid food and have a bowel movement sooner compared to a placebo (an inactive substance). You might be able to join if you are between 18 and 85 years old, are having this specific type of bladder cancer surgery, and meet other health criteria. The study aims to enroll 136 participants, but the current recruitment status is unclear.

Study design
This is a randomized, double-blind study where participants will receive either Alvimopan or a placebo. It is a single-center study aiming to include 136 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your return of bowel function will be measured from the day of surgery up to Day 30.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03216525

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

Recruiting
PHASE3Ages 18–85InterventionalTreatment
Brigham and Women's Hospital
~136 participants
Updated 2023-09-28 on ClinicalTrials.gov
What's tested:AlvimopanPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to Return of Bowel Function
Measured over From Day of surgery (Day 0) to Day 30

Conditions

Bladder Cancer

Explore related trials

Bladder Carcinoma

NCT03216525

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Brigham and Women's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Mark A Preston, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Martin Barylak
[email protected]
6175258274
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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
Able to understand the study procedures, agreed to participate in the study program, and voluntarily provided informed consent

Exclusion

Patients who met any of the following criteria were excluded from participating in the study:
Scheduled for a partial cystectomy
Previous total colectomy, gastrectomy, or gastric bypass, or functional colostomy or ileostomy
More than three doses of opioids (oral or parenteral) within 7 days before the day of surgery
Chemotherapy for bladder cancer within 1 month of scheduled surgery; prior neoadjuvant chemotherapy allowed.
Pregnant (identified by a positive serum pregnancy test administered after the initial screening process and before the commencement of study activities) or lactating, or not postmenopausal (no menses for at least 1 year) and of childbearing potential and not using an accepted method of birth control (i.e, surgical sterilization; intrauterine contraceptive device; oral contraceptive, diaphragm, or condom in combination with contraceptive cream, jelly, or foam; or abstinence) (Participants will be asked to use birth control for the entire study and for at least 2 weeks after the last dose of study drug.)
Participated in another investigational drug or medical device study within 30 days of surgery or planning to be enrolled in another investigational drug or medical device study or any study in which active patient participation was required outside normal hospital data collection during the course of this study
Clinically significant laboratory abnormalities at screening that would have resulted in the cancellation of surgery
Using illicit drugs or abusing alcohol
History of previous surgeries, illness, or behavior (eg, depression, psychosis) that in the opinion of the investigator might have confounded the study results or might have posed additional risk in administering the study procedures
Patients with severe dementia (as determined from medical records and history. Severe dementia will be defined as dementia that impacts daily functioning.)
Patients with severe hepatic impairment.
Patients with end-stage renal disease.
Patients with heart failure. .
Patients with complete gastrointestinal obstruction.

What this trial measures

  • Time to Return of Bowel FunctionFrom Day of surgery (Day 0) to Day 30

    To achieve quicker time to return bowel function measured by a composite endpoint of both upper GI recovery (GI-2 recovery = \[first toleration of solid food\] and lower (first bowel movement) gastrointestinal recovery, taking Alvimopan during radical cystectomy, compared to placebo.