MedTrace Logo

Accelerating Gastrointestinal Recovery

NCT01704651 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2016-10-24

Study results available
· View outcomes & findings →

Summary

This study is designed to determine whether an oral perioperative medication (alvimopan--a selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian cancer.

Conditions

Interventions

DRUG

Alvimopan

Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative.

DRUG

Placebo

Perioperative administration of placebo, at same dosing interval as study drug.

Sponsors & Collaborators

  • Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    collaborator INDUSTRY

  • Jamie N. Bakkum-Gamez

    lead OTHER

Principal Investigators

  • Jamie Bakkum-Gamez, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-08-31
Completion
2015-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01704651 on ClinicalTrials.gov