Status:
COMPLETED
Safety and Efficacy of Once-daily Oral Administrations of TZP-102 for Gastroparesis in Patients With Diabetes Mellitus
Lead Sponsor:
Tranzyme, Inc.
Conditions:
Gastroparesis
Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00889486
Start Date
April 1 2009
End Date
April 1 2010
Last Update
December 11 2012
Active Locations (23)
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1
Long Beach VA Medical Center
Long Beach, California, United States, 90822
2
Impact Clinical Trials
Los Angeles, California, United States, 90036
3
California Pacific Medical Center Research Institute
San Francisco, California, United States, 94115
4
University of South Florida/Tampa General Hospital
Tampa, Florida, United States, 33606