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Safety and Efficacy of Once-daily Oral Administrations of TZP-102 for Gastroparesis in Patients With Diabetes Mellitus - NCT00889486-90822(Clinical Trial 329411)



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City:  Long Beach
State:  
CA
Zip Code: 90822
Conditions: Gastroparesis - Diabetes Mellitus
Purpose: 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.
Study summary:
Criteria: Inclusion Criteria: - 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. Exclusion Criteria: - Persistent daily vomiting - Gastrectomy, obesity surgery, fundoplication, or vagotomy/pyloropasty. - 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.
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Data Source: ClinicalTrials.gov
Date Processed: April 13, 2010
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