Diabetic Gastroparesis Efficacy/Safety Study of TZP-102 (DIGEST)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Change from baseline in symptoms associated with diabetic gastroparesis [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Change from baseline in health-related quality of life [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Adverse events (AEs), vital signs, ECGs, clinical laboratory parameters [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||February 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: TZP-102 three times a day
10 mg TZP-102 will be taken 30 minutes prior to each main meal for a total of three daily doses.
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
Placebo Comparator: Placebo three times a day
Placebo will be taken 30 minutes prior to each main meal for a total of three daily doses.
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
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|Study Director:||Elsa Mondou, M.D.||Tranzyme, Inc.|