Status:
COMPLETED
Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Diabetic Gastroparesis
Lead Sponsor:
Tranzyme, Inc.
Conditions:
Gastroparesis
Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- Subject has type 1 or type 2 diabetes mellitus
- Subject has documented diagnosis of gastroparesis by:
- Delayed gastric emptying (gastric retention ≥60% at 2h and ≥10% at 4 h; based on scintigraphy -4h standardized radionuclide solid meal)
- A minimum 3 month history of chronic upper abdominal discomfort (two or more: chronic postprandial fullness, bloating, epigastric discomfort, early satiety, belching after meal, postprandial nausea, vomiting)
- Subject has normal upper endoscopy
- If female, must be permanently sterilized or postmenopausa.
Exclusion
- Patient has received any investigational drug within the preceding 30 days
- Patient is taking unstable doses of medication that affects gastric motility
- Patient has co-morbid condition
- Patient has a positive laboratory test result for hepatitis B, hepatitis C, HIV, or controlled substances.
- Patient has a history of a psychiatric disorder (including drug or alcohol addiction) requiring care by a psychiatrist or psychologist within the preceding 12 months.
- Patient has a recent,adult history of clinically significanthypersensitivity reaction(s) to any drug.
- Patient has known history of alcoholism
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00639808
Start Date
August 1 2006
End Date
March 1 2008
Last Update
March 20 2008
Active Locations (3)
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1
Aarhus Hospital
Aarhus, Denmark
2
Hvidore Hospital
Copenhagen, Denmark
3
Karolinska University Hospital
Stockholm, Sweden