NCT00612014

Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Severe Diabetic Gastroparesis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-ranging Study to Assess the Efficacy and Safety of TZP-101 When Administered as a 30 Minute I.V. Infusion to Subjects With Severe Gastroparesis Due to Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (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 treatment of symptomatic gastroparesis due to diabetes.

Detailed description

Subjects are randomized according to an adaptive randomization procedure.

Conditions

• Gastroparesis
• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	5% dextrose in water	60 ml IV infusion over 30 minutes
DRUG	TZP-101	40 micrograms/kg iv 2ml/minute for 30 minutes 1 infusion/day for 4 consecutive days
DRUG	TZP-101	80 micrograms/kg iv 2ml/minute for 30 minutes 1 infusion/day for 4 consecutive days
DRUG	TZP-101	160 micrograms/kg iv 2ml/minute for 30 minutes 1 infusion/day for 4 consecutive days
DRUG	TZP-101	320 micrograms/kg iv 2ml/minute for 30 minutes 1 infusion/day for 4 consecutive days
DRUG	TZP-101	600 micrograms/kg iv 2ml/minute for 30 minutes 1 infusion/day for 4 consecutive days

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-02-01
• Completion: 2009-03-01
• First posted: 2008-02-11
• Last updated: 2012-12-07

Locations

12 sites across 6 countries: United States, Denmark, India, Norway, Sweden, United Kingdom