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A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy

NCT00708201 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2016-01-08

Study results available
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Summary

This study is being conducted to determine whether alvimopan can accelerate recovery of gastrointestinal function following radical cystectomy when compared with a placebo. Secondary objectives of the study are:

* to evaluate the effect of alvimopan on hospital length of stay
* to evaluate the effect of alvimopan on prespecified postoperative ileus (POI)-related morbidities
* to evaluate the overall and cardiovascular safety of alvimopan

Conditions

  • Postoperative Ileus

Interventions

DRUG

Alvimopan

DRUG

Placebo

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00708201 on ClinicalTrials.gov