An Efficacy and Safety Study of Cisapride for Improving Symptoms Associated With 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 assess the effectiveness of cisapride at improving symptoms associated with gastroparesis (a stomach disorder) in patients with diabetes mellitus.

Detailed Description
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This is a double-blind (neither the physician nor the patient will know the name of assigned treatment) study to determine the effectiveness of cisapride tablets compared to placebo tablets (a tablet identical in appearance to cisapride but does not contain active drug) at improving symptoms associated with diabetic gastroparesis when administered orally (by mouth) to patients with insulin dependent or non-insulin dependent diabetes mellitus. Gastroparesis is a disorder also called delayed gastric emptying, in which the stomach takes too long to empty food into the small intestine for digestion. Symptoms of gastroparesis may include vomiting, nausea, early feeling of fullness after only a few bites of food, weight loss due to poor absorption of nutrients or low calorie intake, abdominal bloating, poor glycemic (blood sugar) control, lack of appetite, and pain in the stomach area. Patients will take study drug (one 10-mg tablet of cisapride, or one tablet of placebo), orally, 4 times a day, for a period of 8 weeks. Study drug will be taken approximately 15 minutes before each meal and, with a beverage, before going to bed.

Official Title
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Double-Blind, Randomized, Placebo-Controlled Trial to Assess Efficacy and Safety of R051619 (Cisapride 10 mg Q.I.D.) Versus Placebo for the Improvement of Symptoms Associated With Exacerbations of Gastroparesis, After Failure of Other Treatments, in Patients With Diabetes Mellitus

Conditions
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Gastroparesis, Diabetes Mellitus

Intervention / Treatment
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* Drug: Cisapride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with insulin dependent or non-insulin dependent diabetes mellitus Experienced inadequate responses to, or have been intolerant of, treatment with at least one previous drug therapy for gastroparesis Have exacerbation of gastroparesis symptoms requiring medical attention Demonstrate delayed gastric emptying as assessed by a [1-13C]-Sodium Acetate Breath Test within 14 days before randomization Exclusion Criteria: Received prior treatment with cisapride Have a glycosylated hemoglobin (HbA1c) >10% at screening, as determined by clinical laboratory testing Have any upper gastrointestinal (GI) pathology other than diabetic gastroparesis that would require therapy other than that provided in this trial Have any organic/neurological disease that is suspected to be causing gastroparesis, other than diabetes Currently vomiting, or receiving therapy for a severe exacerbation of gastroparesis, that would prevent the patient from receiving oral therapy or a diet

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: 001<br>Cisapride One 10-mg tablet taken orally 4 times a day for up to 8 weeks. | Drug: Cisapride<br>* One 10-mg tablet taken orally 4 times a day for up to 8 weeks.<br>|
| Experimental: 002<br>Placebo One tablet taken orally 4 times a day for up to 8 weeks. | Drug: Placebo<br>* One tablet taken orally 4 times a day for up to 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in Gastroparesis Cardinal Symptoms Index (GCSI) score |  | At baseline (Visit 2) and weekly during the treatment phase of the trial for up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse events reported |  | For the duration of the study (up to 8 weeks) | 
| The type of adverse events reported |  | For the duration of the study (up to 8 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cisapride (PREPULSID), Placebo, Diabetes mellitus, Diabetic gastroparesis