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?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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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Status
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…
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
* Able to understand the study procedures, agreed to participate in the study program, and voluntarily provided informed consent
Exclusion criteria:
* 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.
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