Safety and Efficacy of Once-daily Oral Administrations of TZP-102 for Gastroparesis in Patients With Diabetes Mellitus - NCT00889486-46012 (Clinical Trial 289226)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy289226.aspx
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Anderson |
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State:
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IN |
| Zip Code: |
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46012 |
| Conditions: |
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Gastroparesis - Diabetes Mellitus |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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.
- 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 demonstated at the Baseline Visit.
Exclusion Criteria:
- Persistent daily vomiting
- Gastrectomy, obesity surgery, fundoplication, or vagotomy/pyloropasty.
- NG, PEG or PEJ feeding tube.
- Required in-patient hospitalization for treatment of gastroparesis within 2 months
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 diarrhea.
- Diabetic ketoacidosis within 30 days prior to study entry.
- History of any eating disorder within 2 years prior to study entry.
- 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 Hepatitis B, Hepatitis C or HIV infection.
- 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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| Study is available at: |
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Saint John's Research Institute
Anderson, IN 46012
United States
Primary Contact:
Lisa Ruehr, RN,BSN
Email: lhruehr@sjhsnet.org
Phone: 765-648-4106 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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