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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Terminated

CT.gov ID

NCT01281540

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroparesis	Drug: Cisapride Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2003

Actual Study Completion Date :

Nov 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 001 Cisapride one 10 mg tablet 4 times a day for 8 weeks	Drug: Cisapride one 10 mg tablet 4 times a day for 8 weeks
Placebo Comparator: 002 Placebo one placebo tablet 4 times a day for 8 weeks	Drug: Placebo one placebo tablet 4 times a day for 8 weeks

Arm

Intervention/Treatment

Experimental: 001

Cisapride one 10 mg tablet 4 times a day for 8 weeks

Drug: Cisapride

one 10 mg tablet 4 times a day for 8 weeks

Placebo Comparator: 002

Placebo one placebo tablet 4 times a day for 8 weeks

Drug: Placebo

one placebo tablet 4 times a day for 8 weeks

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.