Diabetic Gastroparesis Efficacy/Safety Study of TZP-102

Study Overview
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Brief Summary
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The purpose of this study is to test the safety and effectiveness of 10 mg TZP-102 given prior to meals three times a day compared to placebo (capsule that looks like active study drug but contains no active drug), administered for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Evaluation of the Efficacy and Safety of TZP-102 Given Orally Three Times a Day for the Treatment of Symptoms Associated With Diabetic Gastroparesis

Conditions
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Diabetic Gastroparesis

Intervention / Treatment
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* Drug: 10 mg 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 History of symptoms of gastroparesis for at least 3 months leading up to the Screening Visit Documented delayed gastric emptying Upper gastrointestinal obstruction ruled out by endoscopy or barium scan Concomitant medications must be stable for at least 2 weeks leading up to the Screening visit and must be maintained during the study. Females of child-bearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) an acceptable form of contraception Exclusion Criteria: Gastrectomy, bariatric surgery, fundoplication or vagotomy/pyloroplasty Has had or plans to have endoscopic pyloric injections of botulinum toxin within 6 months prior to the Screening Visit or during the study NG, PEG or PEJ feeding tube or inpatient hospitalization for gastroparesis within 2 weeks prior to the Screening Visit Required 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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TZP-102 three times a day<br>10 mg TZP-102 will be taken 30 minutes prior to each main meal for a total of three daily doses. | Drug: 10 mg TZP-102<br>* One oval-shaped, opaque-white, hard gelatin capsule containing active ingredient will be taken orally three times a day for 12 weeks<br>|
| Placebo Comparator: Placebo three times a day<br>Placebo will be taken 30 minutes prior to each main meal for a total of three daily doses. | Drug: Placebo<br>* One oval-shaped, opaque-white, hard gelatin capsule of placebo indistinguishable from active drug will be taken orally three times a day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in symptoms associated with diabetic gastroparesis |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in health-related quality of life |  | 12 Weeks | 
| Adverse events (AEs), vital signs, ECGs, clinical laboratory parameters |  | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic gastroparesis, delayed gastric emptying, gastroparesis, diabetes mellitus, Type 1, diabetes mellitus, Type 2