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

Study:

A Phase 4, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy.

Rationale:

n/a

Purpose:

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

Study Status: Completed

Recruiting:
n/a

Condition Intervention Phase
Postoperative Ileus Drug: alvimopan
Drug: Placebo
Phase 4

Verified by Cubist Pharmaceuticals March, 2012

Sponsored by: Cubist Pharmaceuticals
Information provided by: Cubist Pharmaceuticals
ClinicalTrials.gov identifier: NCT00708201

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio 44195
United States

Lee Techner, DPM., Study Director

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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