An Efficacy and Safety Study of Cisapride in Patients With Chronic Gastroparesis After Failure of Other Treatment Options
Primary Purpose
Gastroparesis
Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cisapride
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gastroparesis focused on measuring Cisapride ( PREPULSID ), Placebo, Idiopathic, Stomach Diseases, Stomach
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
001
002
Arm Description
Cisapride one 10 mg tablet 4 times a day for 8 weeks
Placebo one placebo tablet 4 times a day for 8 weeks
Outcomes
Primary Outcome Measures
The average change from baseline in Gastroparesis Cardinal Symptoms Index (GCSI) score
Secondary Outcome Measures
The number and type of adverse events reported
Full Information
NCT ID
NCT01281540
First Posted
January 20, 2011
Last Updated
January 20, 2011
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1. Study Identification
Unique Protocol Identification Number
NCT01281540
Brief Title
An Efficacy and Safety Study of Cisapride in Patients With Chronic Gastroparesis After Failure of Other Treatment Options
Official Title
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 Idiopathic Gastroparesis, After Failure Of Other Treatment Options
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Terminated
Why Stopped
Sponsor request
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis
Keywords
Cisapride ( PREPULSID ), Placebo, Idiopathic, Stomach Diseases, Stomach
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
001
Arm Type
Experimental
Arm Description
Cisapride one 10 mg tablet 4 times a day for 8 weeks
Arm Title
002
Arm Type
Placebo Comparator
Arm Description
Placebo one placebo tablet 4 times a day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Cisapride
Intervention Description
one 10 mg tablet 4 times a day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
one placebo tablet 4 times a day for 8 weeks
Primary Outcome Measure Information:
Title
The average change from baseline in Gastroparesis Cardinal Symptoms Index (GCSI) score
Time Frame
At baseline (Week 0) up to 8 weeks
Secondary Outcome Measure Information:
Title
The number and type of adverse events reported
Time Frame
From time of first dose to the last dose (up to 8 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
An Efficacy and Safety Study of Cisapride in Patients With Chronic Gastroparesis After Failure of Other Treatment Options
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