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

NCT ID: NCT03216525

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2024-06-01

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.

Detailed Description

A prospective, randomized, single-center double blind trial of Alvimopan versus placebo for improving patient outcomes and cost during radical cystectomy and urinary diversion will be performed. A randomized trial is necessary to control for all the known and unknown confounders associated with instituting this novel intervention into a surgical procedure. We will recruit 136 subjects (63 patients in each arm of the study per sample size calculation below, plus additional 10 subjects to account for drop outs). A control group will be administered a placebo in order to directly compare if the Alvimopan intervention is effective.

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Alvimopan

Intervention Type: DRUG

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

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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Alvimopan

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Entereg

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
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mark Preston

Urological Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark A Preston, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Martin Barylak

Role: CONTACT

mbarylak@bwh.harvard.edu

6175258274

Anjali Vasavada

Role: CONTACT

AVASAVADA@BWH.HARVARD.EDU

6175258274

Facility Contacts

Martin Barylak

Role: primary

mbarylak@bwh.harvard.edu

617-525-8274

References

Vora AA, Harbin A, Rayson R, Christiansen K, Ghasemian R, Hwang J, Verghese M. Alvimopan provides rapid gastrointestinal recovery without nasogastric tube decompression after radical cystectomy and urinary diversion. Can J Urol. 2012 Jun;19(3):6293-8.

Reference Type: BACKGROUND

PMID: 22704317 (View on PubMed)

Other Identifiers

2017P000330

Identifier Type: -

Identifier Source: org_study_id