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Opioid Antagonist

Alvimopan for Bladder Cancer

Phase 3
Recruiting
Led By Mark A Preston, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing radical cystectomy and urinary diversion via open or robotic approach
Ileal conduit or ileal neobladder urinary diversion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of discharge (up to day 30)
Awards & highlights

Study Summary

This trial is testing if a drug called Alvimopan can help people recover from a surgery called a radical cystectomy with urinary diversion. The trial will measure how quickly people are able to start eating solid food and have a bowel movement after the surgery.

Who is the study for?
This trial is for adults aged 18-85 undergoing radical cystectomy and urinary diversion for bladder cancer. They must understand the study, consent to participate, have an ASA score of 1-4, and not be pregnant or using inadequate birth control. Exclusions include those with certain past surgeries or conditions like heart failure, severe liver impairment, recent opioid use, drug/alcohol abuse, chemotherapy within a month before surgery, or severe dementia.Check my eligibility
What is being tested?
The trial tests if Alvimopan can speed up the return of bowel function after bladder cancer surgery compared to a placebo. Patients are randomly assigned to receive either Alvimopan or a placebo during their surgical recovery on an enhanced recovery protocol.See study design
What are the potential side effects?
Alvimopan may cause side effects such as digestive issues (like constipation), potential risk of heart attack in people who take it long-term after surgery (though this risk is low when used short-term as in this study), and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having surgery to remove my bladder using either an open or robotic method.
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I have had surgery to redirect urine flow using part of my intestine.
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My health is rated between mild to completely disabling but not at immediate risk of death.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of discharge (up to day 30)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day of discharge (up to day 30) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to Return of Bowel Function
Secondary outcome measures
30 Day Complications
Cost Analysis
Cystectomy
+3 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Oral AlvimopanActive Control1 Intervention
Oral Alvimopan (Entereg, Merck) 12 mg between 30 minutes and 3 hours before surgery start and twice-daily oral doses postoperatively beginning on day one (AM and PM dosing) until hospital discharge or a maximum of 7 days (15 in-hospital doses).
Group II: Matching PlaceboPlacebo Group1 Intervention
Matching placebo between 30 minutes and 3 hours before surgery start and twice-daily oral doses postoperatively beginning on day one (AM and PM dosing) until hospital discharge or a maximum of 7 days (15 in-hospital doses).

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,616 Previous Clinical Trials
11,470,812 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,010 Total Patients Enrolled
Mark A Preston, MDPrincipal InvestigatorBrigham and Women's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age limit for this clinical investigation extend beyond 25 years of age?

"This medical trial has parameters for age eligibility, only accepting applicants between 18 and 85. There are 14 studies specifically geared towards minors and 376 trials designed to meet the needs of seniors."

Answered by AI

Are there any existing opportunities to participate in this clinical trial?

"Clinicaltrials.gov reports that this medical trial is open for enrollment, having been posted on October 1st 2018 and last updated on September 26th 2023."

Answered by AI

Has the U.S. Food and Drug Administration authorized Oral Alvimopan for therapeutic use?

"Our team at Power deems oral alvimopan to be a 3 on the safety scale, considering it is in its final stage of testing and there are ample findings that suggest it is both efficacious and safe."

Answered by AI

How many participants are being monitored for this trial?

"Affirmative. As per clinicaltrials.gov, this medical trial is actively in pursuit of enrollees and was initially listed on the 1st October 2018. The most recent update to its data occurred on 26th September 2023 with 136 subjects required from a single location."

Answered by AI

Has research been conducted into Oral Alvimopan's feasibility?

"Two clinical trials involving Oral Alvimopan are currently up and running, one of which is in Phase 3. While a majority of the studies take place within Boston, Massachusetts; two other places have active clinical trials with regard to this medication."

Answered by AI

What demographics are eligible to engage in this experiment?

"This clinical trial is recruiting 136 participants aged 18 to 85 suffering from bladder cancer. To qualify, one needs to have undergone a radical cystectomy and urinary diversion via open or robotic approach; be of male or female gender with an ASA Physical Status Score ranging between 1-4; have either ileal conduit or ileal neobladder urinary diversion; comprehend the study procedures, willingly consenting to participate in this program."

Answered by AI

Is the current clinical trial a pioneering endeavor?

"At present, there are two active trials being conducted for Oral Alvimopan in 2 cities across 1 nation. The beginning of testing dates back to 2018 when Merck Sharp & Dohme LLC launched a Phase 3 trial with 136 subjects which was ultimately successful. Since then, 19478 clinical studies have been completed."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol
Mark Preston 2018. "Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03216525.
~21 spots leftby Apr 2025
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