Safety and Efficacy of Once-daily Oral Administrations of TZP-102 for Gastroparesis in Patients With Diabetes Mellitus
NCT ID: NCT00889486
Last Updated: 2012-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
92 participants
INTERVENTIONAL
2009-04-30
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Four placebo capsules taken orally once per day for 28 days
Placebo
10 mg TZP-102
One 10 mg TZP-102 Capsule and three placebo capsules taken orally once per day for 28 days
TZP-102
Placebo
20 mg TZP-102
Two 10 mg TZP-102 Capsules and two placebo capsules taken orally once per day for 28 days
TZP-102
Placebo
40 mg TZP-102
Four 10 mg TZP-102 Capsules taken orally once per day for 28 days
TZP-102
Interventions
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TZP-102
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Tranzyme, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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TZP-102-CL-G002
Identifier Type: -
Identifier Source: org_study_id