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Safety and Efficacy of IV Infusion of TZP-101 for POI After Major Open Abdominal Surgery

Postoperative Ileus Clinical Trial

Official title:
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess Efficacy and Safety of TZP-101 When Administered as 30 Minute i.v. Infusion for POI to Subjects Undergoing Major Open Abdominal Surgery

Clinical Trial Summary

The purpose of this study is to determine whether TZP-101 is effective in the management of post operative ileus in subjects undergoing major open abdominal surgery (i.e. partial large bowel resection).

Clinical Trial Description

Subjects will be randomized according to an adaptive randomization procedure. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00617552
Study type Interventional
Source Tranzyme, Inc.
Contact
Status Completed
Phase Phase 2
Start date July 2007
Completion date August 2008
View Details
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