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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
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroparesis focused on measuring Cisapride ( PREPULSID ), Placebo, Idiopathic, Stomach Diseases, Stomach

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 20, 2011
    Last Updated
    January 20, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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    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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