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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Evaluation of the Safety and Efficacy of Once-Daily Administrations of TZP 102 for the Treatment of Symptomatic Gastroparesis in Patients With Diabetes Mellitus

Conditions
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Gastroparesis, Diabetes Mellitus

Intervention / Treatment
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* Drug: TZP-102
* Drug: Placebo


Participation Criteria
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Eligibility 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 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/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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Four placebo capsules taken orally once per day for 28 days | Drug: Placebo<br> <br> |
| Experimental: 10 mg TZP-102<br>One 10 mg TZP-102 Capsule and three placebo capsules taken orally once per day for 28 days | Drug: TZP-102<br> <br> Drug: Placebo<br> <br> |
| Experimental: 20 mg TZP-102<br>Two 10 mg TZP-102 Capsules and two placebo capsules taken orally once per day for 28 days | Drug: TZP-102<br> <br> Drug: Placebo<br> <br> |
| Experimental: 40 mg TZP-102<br>Four 10 mg TZP-102 Capsules taken orally once per day for 28 days | Drug: TZP-102<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in gastric half-emptying time |  | study days 1 and 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in gastroparesis symptoms and health-related quality of life |  | study days 8, 15 and 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastroparesis, diabetes mellitus, delayed gastric emptying