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

Sponsored by:	Tranzyme, Inc.
Information provided by:	Tranzyme, Inc.
ClinicalTrials.gov Identifier:	NCT00639808

Purpose

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.

Condition	Intervention	Phase
Gastroparesis Diabetes Mellitus	Drug: 5% dextrose in water Drug: TZP-101	Phase I

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Tranzyme, Inc.:

Primary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	August 2006
Study Completion Date:	March 2008
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: 5% dextrose in water 60 ml IV infusion over 30 minutes
2: Experimental TZP-101	Drug: TZP-101 1 infusion: IV 2ml/min for 30 minutes for 1 day of either 160, 320 or 600 micrograms/kg

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639808

Locations

Denmark
Hvidore Hospital
Copenhagen, Denmark
Aarhus Hospital
Aarhus, Denmark
Sweden
Karolinska University Hospital
Stockholm, Sweden

Sponsors and Collaborators

Tranzyme, Inc.

More Information

Responsible Party:	Tranzyme, Inc. ( Gordana Kosutic, MD; VP Clinical & Regulatory Affairs )
Study ID Numbers:	TZP-101-CL-002, EudraCT 2006-002730-38
Study First Received:	March 13, 2008
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00639808
Health Authority:	United States: Food and Drug Administration; Denmark: Danish Medicines Agency

Keywords provided by Tranzyme, Inc.:

delayed gastric emptying
symptomatic gastroparesis
diabetes mellitus

Study placed in the following topic categories:

Metabolic Diseases
Gastrointestinal Diseases
Diabetes Mellitus
Endocrine System Diseases
Paralysis
Signs and Symptoms
Stomach Diseases

Digestive System Diseases
Neurologic Manifestations
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Gastroparesis

ClinicalTrials.gov processed this record on January 16, 2009