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Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC

NCT03352414 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-08-18

Study results available
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Summary

The purpose of this study is to investigate the ability of alvimopan to reduce the time to return of bowel function in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. Half of the participants will receive alvimopan or and half will receive placebo immediately before and for up to seven days after surgery.

Conditions

  • Ileus

Interventions

DRUG

Alvimopan

alvimopan pill

DRUG

Placebo

placebo pill

Sponsors & Collaborators

Principal Investigators

  • Joel M Baumgartner, MD, MAS · UCSD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-08
Primary Completion
2020-04-28
Completion
2020-04-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT03352414 on ClinicalTrials.gov