Safety and Efficacy of Once-daily Oral Administrations of TZP-102 for Gastroparesis in Patients With Diabetes Mellitus

December 7, 2012 updated by: Tranzyme, Inc.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Evaluation of the Safety and Efficacy of Once-Daily Administrations of TZP 102 for the Treatment of Symptomatic Gastroparesis in Patients With Diabetes Mellitus

The purpose of this study is to evaluate the effect of TZP-102 on gastric emptying rate, gastroparesis symptoms and health-related quality of life in diabetic patients with gastroparesis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2

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
      • Aalborg, Denmark
        • Aalborg Hospital
      • Aarhus, Denmark
        • Aarhus University Hospital
      • Gentofte, Denmark
        • Steno Diabetes Center
      • Odense, Denmark
        • Odense University Hospital
  • Norway
      • Bergen, Norway
        • Haukeland University Hospital
  • Poland
      • Bialystok, Poland
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
      • Lodz, Poland
        • Oddzial Kliniczny Diabetologii Samodzielny Publiczny Zaklad
      • Warsaw, Poland
        • Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital
  • United Kingdom
      • Ipswich, United Kingdom
        • Ipswich Hospital NHS Trust
      • Leicester, United Kingdom
        • Leicester Royal Infirmary
      • Manchester, United Kingdom
        • Wellcome Truest Clinical Research Facility
  • United States
    • California
      • Long Beach, California, United States, 90822
        • Long Beach VA Medical Center
      • Los Angeles, California, United States, 90036
        • Impact Clinical Trials
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center Research Institute
    • Florida
      • Tampa, Florida, United States, 33606
        • University of South Florida/Tampa General Hospital
    • Indiana
      • Anderson, Indiana, United States, 46012
        • Saint John's Research Institute
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Univ. of Louisville Medical-Dental Complex
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
    • Texas
      • El Paso, Texas, United States, 79905
        • Texas Tech Univ. Health Sciences Center Dept. of Medicine

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

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to 80 years of age, inclusive.
  • Type 1 or type 2 diabetes mellitus.
  • Female patients of childbearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) an acceptable method of contraception.
  • HbA1c level less than/equal to 10.0 % at the Screening Visit.
  • Diagnosis of gastroparesis including (all three of the following requirements apply): i. Documented delayed gastric emptying; ii. A greater than 3 month history of symptoms of gastroparesis; iii. A GCSI Total Score greater than/equal to 2.66 at the Screening Visit and greater than/equal to 1.90 at the Day 1 visit.
  • Upper gastrointestinal obstruction ruled out by endoscopy or barium scan.
  • Concomitant medications must be stable for at least 2 weeks leading up to the Baseline Visit and be maintained during the study.
  • Body Mass Index (BMI) < 35.
  • Delayed gastric emptying by breath test demonstrated at the Baseline Visit.

Exclusion Criteria:

  • Persistent daily vomiting
  • Gastrectomy, obesity surgery, fundoplication, or vagotomy/pyloroplasty.
  • Pyloric Botox within 6 months prior to Screening Visit.
  • NG, PEG or PEJ feeding tube.
  • Required in-patient hospitalization for treatment of gastroparesis within 2 weeks prior to the Screening Visit.
  • Parenteral nutrition for treatment of gastroparesis within 2 months prior to the Screening Visit.
  • Active gastric pacemaker within 3 months prior to the Screening Visit.
  • Participation in an investigational study within 30 days prior to study entry.
  • Chronic severe diarrhea.
  • Diabetic ketoacidosis requiring hospitalization within 30 days prior to study entry.
  • History of any eating disorder within 2 years prior to study entry.
  • Significant chronic obstructive pulmonary disease or chronic asthma.
  • Patient is a heavy smoker, and/or unable or unwilling to abstain from smoking during each of the three study visits during which the gastric emptying breath tests will be performed.
  • History of risk factors for Torsades de Pointes.
  • Patient requires treatment with certain concomitant medications known to have a clinically recognized risk for Torsades de Pointes.
  • History of acute myocardial infarction (MI) or unstable angina within 12 months prior to study entry.
  • History of any psychiatric disorder or cognitive impairment that would interfere with participation in the study.
  • History of alcohol dependency within 2 years prior to study entry.
  • Taking opiates for abdominal pain.
  • History of HIV infection.
  • History of Hepatitis B or C currently exhibiting symptoms expected to worsen during course of study.
  • Requires dialysis or has severely impaired renal function.
  • Severe impairment of liver function.
  • Uncontrolled hypo- or hyperthyroidism.
  • History of adrenal insufficiency.
  • Pregnant or is breast-feeding.
  • Allergic to or intolerant of wheat, egg, soy or milk products.
  • Patient requires a gluten-free diet.
  • Any other medical condition or social circumstance that, in the investigator's opinion, makes it inappropriate for the patient to participate in this clinical trial.

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Four placebo capsules taken orally once per day for 28 days
Drug: Placebo
Experimental: 10 mg TZP-102
One 10 mg TZP-102 Capsule and three placebo capsules taken orally once per day for 28 days
Drug: Placebo
Drug: TZP-102
Experimental: 20 mg TZP-102
Two 10 mg TZP-102 Capsules and two placebo capsules taken orally once per day for 28 days
Drug: Placebo
Drug: TZP-102
Experimental: 40 mg TZP-102
Four 10 mg TZP-102 Capsules taken orally once per day for 28 days
Drug: TZP-102

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change from baseline in gastric half-emptying time
Time Frame: study days 1 and 28
study days 1 and 28

Secondary Outcome Measures

Outcome Measure
Time Frame
change from baseline in gastroparesis symptoms and health-related quality of life
Time Frame: study days 8, 15 and 28
study days 8, 15 and 28

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

April 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

April 28, 2009

First Submitted That Met QC Criteria

April 28, 2009

First Posted (Estimate)

April 29, 2009

Study Record Updates

Last Update Posted (Estimate)

December 11, 2012

Last Update Submitted That Met QC Criteria

December 7, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TZP-102-CL-G002

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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