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Sponsored by: |
Tranzyme, Inc. |
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Information provided by: | Tranzyme, Inc. |
ClinicalTrials.gov Identifier: | NCT00639808 |
The purpose of this study is to determine whether TZP-101 is safe in people with diabetes. Also to determine if TZP-101 is effective in increasing the gastric emptying rate in diabetic patients.
Condition | Intervention | Phase |
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Gastroparesis Diabetes Mellitus |
Drug: 5% dextrose in water Drug: TZP-101 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Multicenter, Randomized, Double-Blind, Placebo Controlled, Crossover Single Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Effect on Gastric Emptying of TZP-101 IV Infusion in Diabetic Gastroparesis Patients |
Enrollment: | 10 |
Study Start Date: | August 2006 |
Study Completion Date: | March 2008 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator |
Drug: 5% dextrose in water
60 ml IV infusion over 30 minutes
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2: Experimental
TZP-101
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Drug: TZP-101
1 infusion: IV 2ml/min for 30 minutes for 1 day of either 160, 320 or 600 micrograms/kg
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Tranzyme, Inc. ( Gordana Kosutic, MD; VP Clinical & Regulatory Affairs ) |
Study ID Numbers: | TZP-101-CL-002, EudraCT 2006-002730-38 |
Study First Received: | March 13, 2008 |
Last Updated: | March 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00639808 |
Health Authority: | United States: Food and Drug Administration; Denmark: Danish Medicines Agency |
delayed gastric emptying symptomatic gastroparesis diabetes mellitus |
Metabolic Diseases Gastrointestinal Diseases Diabetes Mellitus Endocrine System Diseases Paralysis Signs and Symptoms Stomach Diseases |
Digestive System Diseases Neurologic Manifestations Endocrinopathy Glucose Metabolism Disorders Metabolic disorder Gastroparesis |