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Affects of Once-daily Oral Administration of TZP-102 on the Treatment of Symptoms Associated With Diabetic Gastroparesis

NCT01452815 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2013-04-25

No results posted yet for this study

Summary

The purpose of this study is to test the safety and effectiveness of two dosage levels (10mg and 20mg) of TZP-102 compared to placebo (capsule that looks like the study drug but contains no active drug), administered once-daily for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis.

Conditions

  • Gastroparesis
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2

Interventions

DRUG

Placebo

Two #2 oval shaped,opaque-white, hard gelatin shell capsules containing inactive ingredients taken orally once daily for 12 weeks.

DRUG

10mg TZP-102

One 10mg #2 oval shaped, opaque-white, hard gelatin shell capsule containing active ingredients and one placebo capsule each taken orally once daily for 12 Weeks

DRUG

20mg TZP-102

Two 10mg #2 oval shaped, opaque-white, hard gelatin shell capsules containing active ingredients

Sponsors & Collaborators

  • Tranzyme, Inc.

    lead INDUSTRY

Principal Investigators

  • Connie Cosentino · Tranzyme Pharma

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
2011-09-30
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States
  • Belgium
  • Denmark
  • Finland
  • Germany
  • Norway
  • Poland
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01452815 on ClinicalTrials.gov