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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tranzyme, Inc.

Criteria

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.