Diabetic Gastroparesis Efficacy/Safety Study of TZP-102 (DIGEST)

December 18, 2012 updated by: Tranzyme, Inc.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Evaluation of the Efficacy and Safety of TZP-102 Given Orally Three Times a Day for the Treatment of Symptoms Associated With Diabetic Gastroparesis

The purpose of this study is to test the safety and effectiveness of 10 mg TZP-102 given prior to meals three times a day compared to placebo (capsule that looks like active study drug but contains no active drug), administered for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

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

  • Poland
      • Bialystok, Poland, 15732
        • Tranzyme Investigational Site
      • Bialystok, Poland, 15950
        • Tranzyme Investigational Site
      • Bydgoszcz, Poland, 85094
        • Tranzyme Investigational Site
      • Kielce, Poland, 25035
        • Tranzyme Investigational Site
      • Krakow, Poland, 31530
        • Tranzyme Investigational Site
      • Lodz, Poland, 90251
        • Tranzyme Investigational Site
      • Lublin, Poland, 20090
        • Tranzyme Investigational Site
      • Lublin, Poland, 20607
        • Tranzyme Investigational Site
      • Olsztyn, Poland, 10561
        • Tranzyme Investigational Site
      • Rzeszow, Poland, 35073
        • Tranzyme Investigational Site
      • Warsaw, Poland, 02097
        • Tranzyme Investigational Site
      • Zgierz, Poland, 95100
        • Tranzyme Investigational Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Tranzyme Investigational Site
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Tranzyme Investigational Site
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Tranzyme Investigational Site
    • California
      • Long Beach, California, United States, 90822
        • Tranzyme Investigational Site
      • Ventura, California, United States, 93003
        • Tranzyme Investigational Site
    • Florida
      • Hialeah, Florida, United States, 33016
        • Tranzyme Investigational Site
      • Inverness, Florida, United States, 34452
        • Tranzyme Investigational Site
      • Jacksonville, Florida, United States, 32256
        • Tranzyme Investigational Site
      • Miami, Florida, United States, 33144
        • Tranzyme Investigational Site
      • Miami, Florida, United States, 33183
        • Tranzyme Investigational Site
      • New Smyrna Beach, Florida, United States, 32168
        • Tranzyme Investigational Site
    • Indiana
      • Anderson, Indiana, United States, 46106
        • Tranzyme Investigational Site
      • Indianapolis, Indiana, United States, 46202
        • Tranzyme Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Tranzyme Investigational Site
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Tranzyme Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Tranzyme Investigational Site
    • Missouri
      • Mexico, Missouri, United States, 65265
        • Tranzyme Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Tranzyme Investigational Site
      • Salisbury, North Carolina, United States, 28144
        • Tranzyme Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Tranzyme Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Tranzyme Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Tranzyme Investigational Site
    • Texas
      • El Paso, Texas, United States, 79905
        • Tranzyme Investigational Site

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 80 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
  • History of symptoms of gastroparesis for at least 3 months leading up to the Screening Visit
  • Documented delayed gastric emptying
  • Upper gastrointestinal obstruction ruled out by endoscopy or barium scan
  • Concomitant medications must be stable for at least 2 weeks leading up to the Screening visit and must be maintained during the study.
  • Females of child-bearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) an acceptable form of contraception

Exclusion Criteria:

  • Gastrectomy, bariatric surgery, fundoplication or vagotomy/pyloroplasty
  • Has had or plans to have endoscopic pyloric injections of botulinum toxin within 6 months prior to the Screening Visit or during the study
  • NG, PEG or PEJ feeding tube or inpatient hospitalization for gastroparesis within 2 weeks prior to the Screening Visit
  • Required 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

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TZP-102 three times a day
10 mg TZP-102 will be taken 30 minutes prior to each main meal for a total of three daily doses.
Drug: 10 mg TZP-102
One oval-shaped, opaque-white, hard gelatin capsule containing active ingredient will be taken orally three times a day for 12 weeks
Placebo Comparator: Placebo three times a day
Placebo will be taken 30 minutes prior to each main meal for a total of three daily doses.
Drug: Placebo
One oval-shaped, opaque-white, hard gelatin capsule of placebo indistinguishable from active drug will be taken orally three times a day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in symptoms associated with diabetic gastroparesis
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in health-related quality of life
Time Frame: 12 Weeks
12 Weeks
Adverse events (AEs), vital signs, ECGs, clinical laboratory parameters
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

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

Sponsor

Tranzyme, Inc.

Investigators

  • Study Director: Elsa Mondou, M.D., Tranzyme, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2012

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

August 10, 2012

First Submitted That Met QC Criteria

August 10, 2012

First Posted (Estimate)

August 14, 2012

Study Record Updates

Last Update Posted (Estimate)

December 20, 2012

Last Update Submitted That Met QC Criteria

December 18, 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-G004

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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