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

Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastroparesis; Diabetes Mellitus

Intervention: Cisapride (Drug); Placebo (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome:

The number of adverse events reported

The type of adverse events reported

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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: July 2003
Last updated: January 27, 2011

Page last updated: August 23, 2015

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