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

This study has been completed.
Sponsor:
Information provided by:
Tranzyme, Inc.
ClinicalTrials.gov Identifier:
NCT00639808
First received: March 13, 2008
Last updated: March 19, 2008
Last verified: March 2008
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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
Placebo Comparator: 1 Drug: 5% dextrose in water
60 ml IV infusion over 30 minutes
Other Name: D5W
Experimental: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on October 23, 2014