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

NCT03216525 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 2017P000330
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time to Return of Bowel Function

  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.

  From Day of surgery (Day 0) to Day 30

Secondary Outcomes (6)

• Post-operative Length of Stay

  Day of surgery (Day 0) to Day of Discharge (Up to Day 30)

• Post-operative Morbidity

  During hospitalization up to 7 days after surgery

• 30 Day Complications

  Day of surgery (Day 0) to Day 30

• Readmission to Hospital

  Day of Discharge (Up to Day 30)

• Open vs Robotic Radical Cystectomy

  Day of Surgery (Day 0)

Study Arms (2)

Oral Alvimopan

ACTIVE COMPARATOR

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).

Drug: Alvimopan

Matching Placebo

PLACEBO COMPARATOR

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).

Drug: Placebo

Interventions

Alvimopan DRUG

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

Also known as: Entereg

Oral Alvimopan

Placebo DRUG

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

Matching Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 22704317 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

alvimopan

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Mark A Preston, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Barylak

CONTACT

6175258274; mbarylak@bwh.harvard.edu

Anjali Vasavada

CONTACT

6175258274; AVASAVADA@BWH.HARVARD.EDU

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urological Surgeon

Model Details: This is a prospective, randomized, single-center double blind trial of Alvimopan versus placebo for improving patient outcomes and cost during radical cystectomy and urinary diversion.

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: July 13, 2017
• Study Start: October 1, 2018
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)