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

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.