An Efficacy and Safety Study of Cisapride in Patients With Chronic Gastroparesis After Failure of Other Treatment Options

Phase 4

Terminated

• Conditions: Gastroparesis
• Interventions: Drug: Cisapride; Drug: Placebo

• Registration Number: NCT01281540
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary

The purpose of this study is to assess the effectiveness of cisapride in patients with a primary diagnosis of chronic gastroparesis (a stomach disorder) of unknown cause.

Detailed Description

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) in patients with a primary diagnosis of idiopathic gastroparesis (a disorder of unknown cause in which the stomach empties its contents very slowly 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.

Study Timeline

• Study Start: 2003-05
• Study Completion: 2003-11
• Status Verified: 2011-01
• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-01-20
• Last Update Submitted: 2011-01-20
• Study First Posted: 2011-01-24
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Diagnosed with nondiabetic idiopathic gastroparesis and having symptoms for at least 12 weeks in the preceeding 12 months
• Experienced inadequate response, or intolerance to therapy to date
• 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 gycosylated hemoglobin (HbA1c) >7% and bloodglucose of 126 mg/dL (7.0 mmol/L) or greater at screening, as determined by clinical laboratory testing
• Have any upper gastrointestinal (GI) pathology other than idiopathic gastroparesis that would require therapy other than that provided in this trial
• Have any organic/neurological disease that is suspected to be causing gastroparesis
• Currently vomiting, or receiving therapy for a severe exacerbation of gastroparesis, that would prevent the patient from receiving oral therapy or a diet

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
001	Cisapride	Cisapride one 10 mg tablet 4 times a day for 8 weeks
002	Placebo	Placebo one placebo tablet 4 times a day for 8 weeks

Primary Outcome Measures

Name	Time	Method
The average change from baseline in Gastroparesis Cardinal Symptoms Index (GCSI) score	At baseline (Week 0) up to 8 weeks

Secondary Outcome Measures

Name	Time	Method
The number and type of adverse events reported	From time of first dose to the last dose (up to 8 weeks)