An Efficacy and Safety Study of Cisapride for Improving Symptoms Associated With Gastroparesis in Patients With Diabetes Mellitus

Sponsor

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

Overall Status

Terminated

CT.gov ID

NCT01286090

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroparesis Diabetes Mellitus	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) 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

4 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 Gastroparesis, After Failure of Other Treatments, in Patients With Diabetes Mellitus

Study Start Date :

Jul 1, 2003

Actual Study Completion Date :

Oct 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 001 Cisapride One 10-mg tablet taken orally 4 times a day for up to 8 weeks.	Drug: Cisapride One 10-mg tablet taken orally 4 times a day for up to 8 weeks.
Experimental: 002 Placebo One tablet taken orally 4 times a day for up to 8 weeks.	Drug: Placebo One tablet taken orally 4 times a day for up to 8 weeks.

Arm

Intervention/Treatment

Experimental: 001

Cisapride One 10-mg tablet taken orally 4 times a day for up to 8 weeks.

Drug: Cisapride

One 10-mg tablet taken orally 4 times a day for up to 8 weeks.

Experimental: 002

Placebo One tablet taken orally 4 times a day for up to 8 weeks.

Drug: Placebo

One tablet taken orally 4 times a day for up to 8 weeks.

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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.