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Diabetic Gastroparesis Efficacy/Safety Study of TZP-102

NCT01664637 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-12-20

No results posted yet for this study

Summary

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.

Conditions

  • Diabetic Gastroparesis

Interventions

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

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

Sponsors & Collaborators

  • Tranzyme, Inc.

    lead INDUSTRY

Principal Investigators

  • Elsa Mondou, M.D. · Tranzyme, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-01-31
Completion
2013-02-28

Countries

  • United States
  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01664637 on ClinicalTrials.gov