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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639808
• Other study ID #: TZP-101-CL-002
• Secondary ID: EudraCT 2006-002
• Status: Completed
• Phase: Phase 1
• First received: March 13, 2008
• Last updated: March 19, 2008
• Start date: August 2006
• Est. completion date: March 2008

Study information

• Verified date: March 2008
• Source: Tranzyme, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Gastroparesis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Denmark	Aarhus Hospital	Aarhus
Denmark	Hvidore Hospital	Copenhagen
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Tranzyme, Inc.

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-lead ECG data		8 assessments including baseline (prior to start of infusion of study drug) until 24 four hours after start of infusion.	Yes
Secondary	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	No