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

Completed · Phase 2 · Has a placebo group

Conditions studied: Gastroparesis, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01452815

Run by

Tranzyme, Inc.

People needed

201

Starts

2011-09-01

Expected to finish

2012-11-01

Last updated by the study team

2013-04-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Tranzyme Investigational Site — Tucson, Arizona, United States
• Tranzyme Investigational Site — Jonesboro, Arkansas, United States
• Tranzyme Investigational Site — Little Rock, Arkansas, United States
• Tranzyme Investigational Site — Long Beach, California, United States
• Tranzyme Investigational Site — Stanford, California, United States
• Tranzyme Investigational Site — Ventura, California, United States
• Tranzyme Investigational Site — Hialeah, Florida, United States
• Tranzyme Investigational Site — Inverness, Florida, United States
• Tranzyme Investigational Site — Jacksonville, Florida, United States
• Tranzyme Investigational Site — Miami, Florida, United States
• Tranzyme Investigational Site — Miami, Florida, United States
• Tranzyme Investigational Site — New Smyrna Beach, Florida, United States
• Tranzyme Investigational Site — Port Orange, Florida, United States
• Tranzyme Investigational Site — Oak Lawn, Illinois, United States
• Tranzyme Investigational Site — Anderson, Indiana, United States
• Tranzyme Investigational Site — Kansas City, Kansas, United States
• Tranzyme Investigational Site — Monroe, Louisiana, United States
• Tranzyme Investigational Site — Boston, Massachusetts, United States
• Tranzyme Investigational Site — Mexico, Missouri, United States
• Tranzyme Investigational Site — Fayetteville, North Carolina, United States
• Tranzyme Investigational Site — Raleigh, North Carolina, United States
• Tranzyme Investigational Site — Salisbury, North Carolina, United States
• Tranzyme Investigational Site — Winston-Salem, North Carolina, United States
• Tranzyme Investigational Site — Oklahoma City, Oklahoma, United States
• Tranzyme Investigational Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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