Safety and Efficacy of Once-daily Oral Administrations of TZP-102 for Gastroparesis in Patients With Diabetes Mellitus
- Registration Number
- NCT00889486
- Lead Sponsor
- Tranzyme, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 10 mg TZP-102 Placebo One 10 mg TZP-102 Capsule and three placebo capsules taken orally once per day for 28 days Placebo Placebo Four placebo capsules taken orally once per day for 28 days 20 mg TZP-102 TZP-102 Two 10 mg TZP-102 Capsules and two placebo capsules taken orally once per day for 28 days 20 mg TZP-102 Placebo Two 10 mg TZP-102 Capsules and two placebo capsules taken orally once per day for 28 days 10 mg TZP-102 TZP-102 One 10 mg TZP-102 Capsule and three placebo capsules taken orally once per day for 28 days 40 mg TZP-102 TZP-102 Four 10 mg TZP-102 Capsules taken orally once per day for 28 days
- Primary Outcome Measures
Name Time Method change from baseline in gastric half-emptying time study days 1 and 28
- Secondary Outcome Measures
Name Time Method change from baseline in gastroparesis symptoms and health-related quality of life study days 8, 15 and 28
Trial Locations
- Locations (23)
California Pacific Medical Center Research Institute
🇺🇸San Francisco, California, United States
Long Beach VA Medical Center
🇺🇸Long Beach, California, United States
Impact Clinical Trials
🇺🇸Los Angeles, California, United States
Aalborg Hospital
🇩🇰Aalborg, Denmark
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Haukeland University Hospital
🇳🇴Bergen, Norway
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Bialystok, Poland
Odense University Hospital
🇩🇰Odense, Denmark
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Oddzial Kliniczny Diabetologii Samodzielny Publiczny Zaklad
🇵🇱Lodz, Poland
Ipswich Hospital NHS Trust
🇬🇧Ipswich, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
🇵🇱Warsaw, Poland
University of South Florida/Tampa General Hospital
🇺🇸Tampa, Florida, United States
Saint John's Research Institute
🇺🇸Anderson, Indiana, United States
Steno Diabetes Center
🇩🇰Gentofte, Denmark
Wellcome Truest Clinical Research Facility
🇬🇧Manchester, United Kingdom
Univ. of Louisville Medical-Dental Complex
🇺🇸Louisville, Kentucky, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Texas Tech Univ. Health Sciences Center Dept. of Medicine
🇺🇸El Paso, Texas, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States