NCT01664637

Diabetic Gastroparesis Efficacy/Safety Study of TZP-102

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Evaluation of the Efficacy and Safety of TZP-102 Given Orally Three Times a Day for the Treatment of Symptoms Associated With Diabetic Gastroparesis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Tranzyme, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety and effectiveness of 10 mg TZP-102 given prior to meals three times a day compared to placebo (capsule that looks like active study drug but contains no active drug), administered for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis.

Conditions

• Diabetic Gastroparesis

Interventions

Type	Name	Description
DRUG	10 mg TZP-102	One oval-shaped, opaque-white, hard gelatin capsule containing active ingredient will be taken orally three times a day for 12 weeks
DRUG	Placebo	One oval-shaped, opaque-white, hard gelatin capsule of placebo indistinguishable from active drug will be taken orally three times a day for 12 weeks

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-01-01
• Completion: 2013-02-01
• First posted: 2012-08-14
• Last updated: 2012-12-20

Locations

35 sites across 2 countries: United States, Poland