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

January 27, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of adverse events reported
Time Frame: For the duration of the study (up to 8 weeks)
For the duration of the study (up to 8 weeks)
The type of adverse events reported
Time Frame: For the duration of the study (up to 8 weeks)
For the duration of the study (up to 8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion (Actual)

October 1, 2003

Study Registration Dates

First Submitted

January 13, 2011

First Submitted That Met QC Criteria

January 27, 2011

First Posted (Estimate)

January 31, 2011

Study Record Updates

Last Update Posted (Estimate)

January 31, 2011

Last Update Submitted That Met QC Criteria

January 27, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR003946
  • CIS-INT-25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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