Affects of Once-daily Oral Administration of TZP-102 on the Treatment of Symptoms Associated With Diabetic Gastroparesis

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test the safety and effectiveness of two dosage levels (10mg and 20mg) of TZP-102 compared to placebo (capsule that looks like the study drug but contains no active drug), administered once-daily for 12 weeks, in diabetic subjects with symptoms associated 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

• History of symptoms of gastroparesis for at least 3 months leading up to the Screening Visit

• Gastric half-emptying time >82 minutes, demonstrated by the Gastric Emptying Breath Test performed at the Screening Visit OR documented delayed gastric emptying within the previous 24 months

• Mild to moderate severity of gastroparesis symptoms during the screening period

• Body Mass Index (BMI) < 45.0 at the Screening Visit

• Glycosylated hemoglobin (HbA1c) level < 11.0% at the Screening 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 must be maintained during the study.

• Females of child-bearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) an acceptable form of contraception.

Exclusion Criteria:

• Persistent daily vomiting

• Gastrectomy, bariatric surgery, fundoplication or vagotomy/pyloroplasty

• Has had or plans to have endoscopic pyloric injections of botulinum toxin within 6 months prior to the Screening Visit or during the study.

• NG, PEG or PEJ feeding tube within 2 weeks prior to the Screening Visit

• Required in-patient hospitalization for treatment of gastroparesis within 2 weeks prior to the Screening Visit

• Required 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

• Participated in an investigational study within 30 days prior to the Screening Visit

• Chronic severe diarrhea

• Diabetic ketoacidosis that required inpatient hospitalization within 30 days prior to the Screening Visit

• History of any eating disorder within 2 years prior to the Screening Visit

• Chronic obstructive pulmonary disease (COPD) or chronic asthma

• Chronic smoker that is unable or unwilling to abstain from smoking during the two visits that the gastric emptying breath test will be performed

• History of risk factors for Torsades de Pointes

• Corrected QT interval calculated using Fredericia's formula >= 500 msec, recorded and confirmed on any of the three ECG assessments performed during the screening period

• Bradycardia or hypotension assessed as clinically-significant by the investigator

• Requires treatment with concomitant medication that is a substrate of Cytochrome P450 isoenzyme 3A4 and known to have a clinically recognized risk for Torsades de Pointes

• History of acute myocardial infarction, unstable angina or a transient (cerebral) ischemic attack within 12 months prior to the Screening Visit

• History of severe depression, psychiatric disorder or cognitive impairment

• History of alcohol or drug abuse or dependency within 2 years prior to the Screening Visit

• Taking opiates for abdominal pain

• Known history of Hepatitis B or C or HIV infection

• Requires dialysis or elevated creatinine at the Screening Visit

• Abnormal liver function tests at the Screening Visit

• Uncontrolled hypo- or hyperthyroidism

• Adrenal insufficiency

• Active malignancy other than basal cell or squamous cell carcinoma of the skin

• Pregnant or breast-feeding

• Allergies to components of the breath test meal or severe lactose intolerance

• 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