NCT00617552

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: Tranzyme, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Subjects will be randomized according to an adaptive randomization procedure.

Conditions

• Postoperative Ileus

Interventions

Type	Name	Description
DRUG	5% dextrose in water	60 ml IV infusion over 30 minutes
DRUG	TZP-101	20 micrograms/kg IV 2ml/minute for 30 minutes
DRUG	TZP-101	40 micrograms/kg IV 2 ml/minute for 30 minutes
DRUG	TZP-101	80 micrograms/kg IV 2ml/minute for 30 minutes
DRUG	TZP-101	160 micrograms/kg IV 2ml/minute over 30 minutes
DRUG	TZP-101	320 micrograms/kg IV 2ml/minute for 30 minutes
DRUG	TZP-101	480 micrograms/kg IV 2ml/minute over 30 minutes
DRUG	TZP-101	600 micrograms/kg IV 2ml/minute for 30 minutes

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-07-01
• Completion: 2008-08-01
• First posted: 2008-02-18
• Last updated: 2012-12-07

Locations

27 sites across 3 countries: United States, India, Romania