Recruiting
Phase 3

Alvimopan

Sponsor:

Brigham and Women's Hospital

Code:

NCT03216525

Conditions

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Alvimopan

Placebo

Study Details

Brief summary:

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.

Conditions

Bladder Cancer

Study ID

NCT03216525

Start date

Oct 1, 2018

Status verified date

Sep, 2023

Completion date

Jun 1, 2024

Anticipated

Primary completion date

Dec 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Oral Alvimopan

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).

placebo comparator: Matching Placebo

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).

Interventions

Alvimopan

To determine if Alvimopan during radical cystectomy with urinary diversion results in faster return of bowel function.

Placebo

To determine if placebo during radical cystectomy with urinary diversion results in faster return of bowel function.

Primary outcome measure

  • Time to Return of Bowel Function [ Time Frame: From Day of surgery (Day 0) to Day 30 ]

Central Contacts and Locations

Central contacts

Martin Barylak

6175258274mbarylak@bwh.harvard.edu

Anjali Vasavada

6175258274AVASAVADA@BWH.HARVARD.EDU

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Martin Barylak

617-525-8274mbarylak@bwh.harvard.edu

Principal Investigator:

Mark A Preston, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Sep 28, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2023-09-28.