Affects of Once-daily Oral Administration of TZP-102 on the Treatment of Symptoms Associated With Diabetic Gastroparesis
|Gastroparesis Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2||Drug: Placebo Drug: 10mg TZP-102 Drug: 20mg TZP-102||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Evaluation of the Efficacy and Safety of Once-Daily Administrations of TZP-102 for the Treatment of Symptoms Associated With Diabetic Gastroparesis|
- Change from baseline in symptoms associated with diabetic gastroparesis [ Time Frame: 12 Weeks ]
- Change from baseline on health-related quality of life [ Time Frame: 12 Weeks ]
- Adverse Events (AEs) [ Time Frame: 12 Weeks ]
- Cardiovascular Parameters (blood pressure, heart rate, 12-Lead ECG) [ Time Frame: 12 Weeks ]
- Clinical Chemistry and Hematology Parameters [ Time Frame: 12 Weeks ]
|Study Start Date:||September 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: 1
Two #2 oval shaped,opaque-white, hard gelatin shell capsules containing inactive ingredients taken orally once daily for 12 weeks.
Drug: 10mg TZP-102
One 10mg #2 oval shaped, opaque-white, hard gelatin shell capsule containing active ingredients and one placebo capsule each taken orally once daily for 12 Weeks
Drug: 20mg TZP-102
Two 10mg #2 oval shaped, opaque-white, hard gelatin shell capsules containing active ingredients
Considered subjects will be screened to determine eligibility for entry into the study. The Screening Visit must take place at least 14 days, but not more than 21 days, before the planned date of study entry (randomization and administration of the first dose of study drug on Study Day 1). The baseline evaluation of gastric emptying must be scheduled at least 7 days (in the U.S.) and 10 days (in Europe) before the Day 1 Visit. Subjects will answer questions relating to their gastroparesis symptoms in an electronic diary (like a palm pilot) beginning on the first day of the screening period.
Eligible subjects will be randomized to receive placebo or one of two dosages of TZP-102 (10mg or 20mg) once daily for 12 weeks. After randomization and administration of the first dose of study drug on Study Day 1 (the Study Entry Visit), subsequent visits to the clinic will be scheduled every two weeks during the 12-week Treatment period and 4-week Follow-Up Period.
All visits will be conducted on an outpatient basis. Visits for a given subject throughout the study should be scheduled to start at approximately the same time, in the morning. Subjects will be instructed to take their daily dose of study drug each morning (when not attending a study visit), at least 30 minutes before breakfast. Subjects will be instructed to not take study drug on the morning of each treatment period visit and to bring study drug supplies with them to the clinic; study drug will be administered in the clinic after all scheduled assessments/procedures (after all pre-dose assessments at each of the Day 1 and Week 12 Visits) are completed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01452815
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|Study Director:||Connie Cosentino||Tranzyme Pharma|