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

Primary Purpose

Bladder Cancer

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Alvimopan
Placebo
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oral Alvimopan

Matching Placebo

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Post-operative Length of Stay
Post operative LOS was determined by the difference between the date of hospital discharge and the date of surgery; that is the postoperative LOS for a participant was calculated as follows:(date of discharge)-(date of surgery).
Post-operative Morbidity
POM defined as need for nasogastric (NG) tube insertion, hospital stay prolonged because of post-operative ileus (POI) beyond 10 days, or readmission to hospital for POI within 7 days after discharge.
30 Day Complications
Any Clavien Grade II-V complication.
Readmission to Hospital
Any readmission to hospital for > 24 hours after discharge.
Open vs Robotic Radical Cystectomy
To determine if Alvimopan during open or robotic radical cystectomy with urinary diversion results in decreased time to GI2 recovery
Cost Analysis
To evaluate costs of surgery and post-operative care between alvimopan and placebo in patients having a radical cystectomy and urinary diversion.

Full Information

First Posted
March 13, 2017
Last Updated
September 26, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03216525
Brief Title
Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol
Official Title
A Randomized, Double-blind, Single-Center Trial of Alvimopan (Entereg) Versus Placebo in Patients Undergoing Radical Cystectomy and Urinary Diversion on an Enhanced Recovery After Surgery ERAS Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigator
Masking Description
double blind design.
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral Alvimopan
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Alvimopan
Other Intervention Name(s)
Entereg
Intervention Description
To determine if Alvimopan during radical cystectomy with urinary diversion results in faster return of bowel function.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
To determine if placebo during radical cystectomy with urinary diversion results in faster return of bowel function.
Primary Outcome Measure Information:
Title
Time to Return of Bowel Function
Description
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.
Time Frame
From Day of surgery (Day 0) to Day 30
Secondary Outcome Measure Information:
Title
Post-operative Length of Stay
Description
Post operative LOS was determined by the difference between the date of hospital discharge and the date of surgery; that is the postoperative LOS for a participant was calculated as follows:(date of discharge)-(date of surgery).
Time Frame
Day of surgery (Day 0) to Day of Discharge (Up to Day 30)
Title
Post-operative Morbidity
Description
POM defined as need for nasogastric (NG) tube insertion, hospital stay prolonged because of post-operative ileus (POI) beyond 10 days, or readmission to hospital for POI within 7 days after discharge.
Time Frame
During hospitalization up to 7 days after surgery
Title
30 Day Complications
Description
Any Clavien Grade II-V complication.
Time Frame
Day of surgery (Day 0) to Day 30
Title
Readmission to Hospital
Description
Any readmission to hospital for > 24 hours after discharge.
Time Frame
Day of Discharge (Up to Day 30)
Title
Open vs Robotic Radical Cystectomy
Description
To determine if Alvimopan during open or robotic radical cystectomy with urinary diversion results in decreased time to GI2 recovery
Time Frame
Day of Surgery (Day 0)
Title
Cost Analysis
Description
To evaluate costs of surgery and post-operative care between alvimopan and placebo in patients having a radical cystectomy and urinary diversion.
Time Frame
Day of surgery (Day 0) to Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Barylak
Phone
6175258274
Email
mbarylak@bwh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Anjali Vasavada
Phone
6175258274
Email
AVASAVADA@BWH.HARVARD.EDU
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Preston, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Barylak
Phone
617-525-8274
Email
mbarylak@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Mark A Preston, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD.
Citations:
PubMed Identifier
22704317
Citation
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.
Results Reference
background

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

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