Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tranzyme, Inc.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
