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| Sponsor: | Tranzyme, Inc. |
|---|---|
| Information provided by (Responsible Party): | Tranzyme, Inc. |
| ClinicalTrials.gov Identifier: | NCT00889486 |
Purpose
The purpose of this study is to evaluate the effect of TZP-102 on gastric emptying rate, gastroparesis symptoms and health-related quality of life in diabetic patients with gastroparesis.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroparesis Diabetes Mellitus |
Drug: 10 mg TZP-102 Drug: placebo Drug: 20 mg TZP-102 Drug: 40 mg TZP-102 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Evaluation of the Safety and Efficacy of Once-Daily Administrations of TZP 102 for the Treatment of Symptomatic Gastroparesis in Patients With Diabetes Mellitus |
| Enrollment: | 92 |
| Study Start Date: | April 2009 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Drug: placebo
four #1 oval opaque white capsules containing inactive ingredients taken orally once per day for 28 days
|
| Experimental: 2 |
Drug: 10 mg TZP-102
one 10 mg TZP-102 Capsule and three placebo capsules taken orally once per day for 28 days
|
| Experimental: 3 |
Drug: 20 mg TZP-102
Two 10 mg TZP-102 capsules and two placebo capsules taken orally once per day for 28 days
|
| Experimental: 4 |
Drug: 40 mg TZP-102
four 10 mg TZP-102 capsules taken orally once per day for 28 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 23 Study Locations
More Information
| Responsible Party: | Tranzyme, Inc. |
| ClinicalTrials.gov Identifier: | NCT00889486 History of Changes |
| Other Study ID Numbers: | TZP-102-CL-G002 |
| Study First Received: | April 28, 2009 |
| Last Updated: | January 12, 2012 |
| Health Authority: | United States: Food and Drug Administration; Denmark: Danish Medicines Agency; Sweden: Medical Products Agency; Norway: Norwegian Medicines Agency; Poland: The Central Register of Clinical Trials; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
gastroparesis diabetes mellitus delayed gastric emptying |
|
Diabetes Mellitus Gastroparesis Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Stomach Diseases |
Gastrointestinal Diseases Digestive System Diseases Paralysis Neurologic Manifestations Signs and Symptoms |