Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Diabetic Gastroparesis
NCT ID: NCT00639808
Last Updated: 2008-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2006-08-31
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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1
5% dextrose in water
60 ml IV infusion over 30 minutes
2
TZP-101
TZP-101
1 infusion: IV 2ml/min for 30 minutes for 1 day of either 160, 320 or 600 micrograms/kg
Interventions
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5% dextrose in water
60 ml IV infusion over 30 minutes
TZP-101
1 infusion: IV 2ml/min for 30 minutes for 1 day of either 160, 320 or 600 micrograms/kg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Tranzyme, Inc.
INDUSTRY
Responsible Party
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Tranzyme, Inc.
Locations
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Aarhus Hospital
Aarhus, , Denmark
Hvidore Hospital
Copenhagen, , Denmark
Karolinska University Hospital
Stockholm, , Sweden
Countries
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Other Identifiers
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EudraCT 2006-002730-38
Identifier Type: -
Identifier Source: secondary_id
TZP-101-CL-002
Identifier Type: -
Identifier Source: org_study_id