Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Diabetic Gastroparesis

Phase 1

Completed

• Conditions: Gastroparesis; Diabetes Mellitus
• Interventions: Drug: TZP-101; Drug: 5% dextrose in water

• Registration Number: NCT00639808
• Lead Sponsor: Tranzyme, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2007-07
• Status Verified: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2008-03-13
• Study First Submitted QC: 2008-03-19
• Last Update Submitted: 2008-03-19
• Study First Posted: 2008-03-20
• Last Update Posted: 2008-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	TZP-101	TZP-101
1	5% dextrose in water	-

Primary Outcome Measures

Name	Time	Method
12-lead ECG data	8 assessments including baseline (prior to start of infusion of study drug) until 24 four hours after start of infusion.

Secondary Outcome Measures

Name	Time	Method
Scintigraphy to measure rate of gastric emptying after ingestion of a radio-labeled meal	Measurements at: 30, 60, 120, 180, 210, and 240 minutes after the meal is eaten

Trial Locations

Locations (3)

Hvidore Hospital; 🇩🇰 Copenhagen, Denmark

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Aarhus Hospital; 🇩🇰 Aarhus, Denmark