Diabetes Mellitus, Gastroparesis
Conditions
Keywords
Cisapride (PREPULSID), Placebo, Diabetes mellitus, Diabetic gastroparesis
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.
Interventions
DRUGCisapride
One 10-mg tablet taken orally 4 times a day for up to 8 weeks.
DRUGPlacebo
One tablet taken orally 4 times a day for up to 8 weeks.
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in Gastroparesis Cardinal Symptoms Index (GCSI) score | At baseline (Visit 2) and weekly during the treatment phase of the trial for up to 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The number of adverse events reported | For the duration of the study (up to 8 weeks) |
| The type of adverse events reported | For the duration of the study (up to 8 weeks) |
Outcome results
None listed