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

• Status: Terminated
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Cisapride

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