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

Completed · Phase 2 · Has a placebo group

Conditions studied: Gastroparesis, Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00889486

Run by

Tranzyme, Inc.

People needed

92

Starts

2009-04-01

Expected to finish

2010-04-01

Last updated by the study team

2012-12-11

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.
• 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 qualify 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.

Where it is running

• Long Beach VA Medical Center — Long Beach, California, United States
• Impact Clinical Trials — Los Angeles, California, United States
• California Pacific Medical Center Research Institute — San Francisco, California, United States
• University of South Florida/Tampa General Hospital — Tampa, Florida, United States
• Saint John's Research Institute — Anderson, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Univ. of Louisville Medical-Dental Complex — Louisville, Kentucky, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• Texas Tech Univ. Health Sciences Center Dept. of Medicine — El Paso, Texas, United States
• Aalborg Hospital — Aalborg, Denmark
• Aarhus University Hospital — Aarhus, Denmark
• Steno Diabetes Center — Gentofte Municipality, Denmark
• Odense University Hospital — Odense, Denmark
• Haukeland University Hospital — Bergen, Norway
• Uniwersytecki Szpital Kliniczny w Bialymstoku — Bialystok, Poland
• Oddzial Kliniczny Diabetologii Samodzielny Publiczny Zaklad — Lodz, Poland
• Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie — Warsaw, Poland
• Karolinska University Hospital — Stockholm, Sweden
• Ipswich Hospital NHS Trust — Ipswich, United Kingdom
• Leicester Royal Infirmary — Leicester, United Kingdom
• Wellcome Truest Clinical Research Facility — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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