Back to resultsSafety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Diabetic Gastroparesis
Primary Purpose
Gastroparesis, Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
5% dextrose in water
TZP-101
Sponsored by
About this trial
This is an interventional treatment trial for Gastroparesis focused on measuring delayed gastric emptying, symptomatic gastroparesis, diabetes mellitus
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Aarhus Hospital
- Hvidore Hospital
- Karolinska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
TZP-101
Outcomes
Primary Outcome Measures
12-lead ECG data
Secondary Outcome Measures
Scintigraphy to measure rate of gastric emptying after ingestion of a radio-labeled meal
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00639808
Brief Title
Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Diabetic Gastroparesis
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tranzyme, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis, Diabetes Mellitus
Keywords
delayed gastric emptying, symptomatic gastroparesis, diabetes mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Arm Description
TZP-101
Intervention Type
Drug
Intervention Name(s)
5% dextrose in water
Other Intervention Name(s)
D5W
Intervention Description
60 ml IV infusion over 30 minutes
Intervention Type
Drug
Intervention Name(s)
TZP-101
Intervention Description
1 infusion: IV 2ml/min for 30 minutes for 1 day of either 160, 320 or 600 micrograms/kg
Primary Outcome Measure Information:
Title
12-lead ECG data
Time Frame
8 assessments including baseline (prior to start of infusion of study drug) until 24 four hours after start of infusion.
Secondary Outcome Measure Information:
Title
Scintigraphy to measure rate of gastric emptying after ingestion of a radio-labeled meal
Time Frame
Measurements at: 30, 60, 120, 180, 210, and 240 minutes after the meal is eaten
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
Facility Name
Aarhus Hospital
City
Aarhus
Country
Denmark
Facility Name
Hvidore Hospital
City
Copenhagen
Country
Denmark
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Diabetic Gastroparesis
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