safety and efficacy of once-daily oral administrations of tzp-102 for gastroparesis in patients with diabetes mellitus

Conditions: Gastroparesis; Diabetes Mellitus

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 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.

Keywords: gastroparesis diabetes mellitus delayed gastric emptying