A Phase 4 interventional study of Cisapride and Placebo in Gastroparesis and Diabetes Mellitus, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Terminated. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-01-31.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 4, Interventional, and Treatment
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.
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.
307 studies on the registry are indexed under Gastroparesis; 67 are open to participants now.
This study's enrollment of 4 is below the median of 44 across 201 interventional studies indexed under Gastroparesis.
Browse Gastroparesis studies →Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cisapride One 10-mg tablet taken orally 4 times a day for up to 8 weeks.
Drug: Cisapride
Placebo One tablet taken orally 4 times a day for up to 8 weeks.
Drug: Placebo
One 10-mg tablet taken orally 4 times a day for up to 8 weeks.
One tablet taken orally 4 times a day for up to 8 weeks.
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
The number of adverse events reported
Time frame: 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)
No study locations are listed for this record.
This study is terminated, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.