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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00639808
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : March 20, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Gastroparesis Diabetes Mellitus Drug: 5% dextrose in water Drug: TZP-101 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1 Drug: 5% dextrose in water
60 ml IV infusion over 30 minutes
Other Name: D5W
Experimental: 2
Drug: TZP-101
1 infusion: IV 2ml/min for 30 minutes for 1 day of either 160, 320 or 600 micrograms/kg

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00639808

Aarhus Hospital
Aarhus, Denmark
Hvidore Hospital
Copenhagen, Denmark
Karolinska University Hospital
Stockholm, Sweden
Sponsors and Collaborators
Tranzyme, Inc.

Responsible Party: Gordana Kosutic, MD; VP Clinical & Regulatory Affairs, Tranzyme, Inc. Identifier: NCT00639808     History of Changes
Other Study ID Numbers: TZP-101-CL-002
EudraCT 2006-002730-38
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: March 20, 2008
Last Verified: March 2008

Keywords provided by Tranzyme, Inc.:
delayed gastric emptying
symptomatic gastroparesis
diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Signs and Symptoms