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

Primary Purpose

Gastroparesis, Diabetes Mellitus

Status

Terminated

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Cisapride

Placebo

About this trial

This is an interventional treatment trial for Gastroparesis focused on measuring Cisapride (PREPULSID), Placebo, Diabetes mellitus, Diabetic gastroparesis

Eligibility Criteria

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

001

002

Arm Description

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

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

Outcomes

Primary Outcome Measures

The change from baseline in Gastroparesis Cardinal Symptoms Index (GCSI) score

Secondary Outcome Measures

The number of adverse events reported

The type of adverse events reported

Full Information

NCT ID

NCT01286090

First Posted

January 13, 2011

Last Updated

January 27, 2011

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT01286090

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Terminated

Why Stopped

Sponsor request

Study Start Date

July 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroparesis, Diabetes Mellitus

Keywords

Cisapride (PREPULSID), Placebo, Diabetes mellitus, Diabetic gastroparesis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

001

Arm Type

Experimental

Arm Description

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

Arm Title

002

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cisapride

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

The change from baseline in Gastroparesis Cardinal Symptoms Index (GCSI) score

Time Frame

At baseline (Visit 2) and weekly during the treatment phase of the trial for up to 8 weeks

Secondary Outcome Measure Information:

Title

The number of adverse events reported

Time Frame

For the duration of the study (up to 8 weeks)

Title

The type of adverse events reported

Time Frame

For the duration of the study (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

Eligibility Criteria

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

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 for Improving Symptoms Associated With Gastroparesis in Patients With Diabetes Mellitus

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