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

March 19, 2008 updated by: Tranzyme, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Drug: 5% dextrose in water
60 ml IV infusion over 30 minutes
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
8 assessments including baseline (prior to start of infusion of study drug) until 24 four hours after start of infusion.

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Measurements at: 30, 60, 120, 180, 210, and 240 minutes after the meal is eaten

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tranzyme, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

March 13, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 20, 2008

Study Record Updates

Last Update Posted (Estimate)

March 20, 2008

Last Update Submitted That Met QC Criteria

March 19, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TZP-101-CL-002
  • EudraCT 2006-002730-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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