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

Johnson & Johnson (J&J)

Status and phase

Terminated

Phase 4

Conditions

Gastroparesis

Diabetes Mellitus

Treatments

Drug: Placebo

Drug: Cisapride

Study type

Interventional

Funder types

Industry

Identifiers

NCT01286090

CR003946

CIS-INT-25

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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