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

NCT03216525 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2023-09-28

No results posted yet for this study

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

Interventions

DRUG

Alvimopan

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

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Mark A Preston, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2023-12-01
Completion
2024-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03216525 on ClinicalTrials.gov