A Phase 4 interventional study of Cisapride and Placebo in Gastroparesis, 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 2011-01-24.
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 in patients with a primary diagnosis of chronic gastroparesis (a stomach disorder) of unknown cause.
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) in patients with a primary diagnosis of idiopathic gastroparesis (a disorder of unknown cause in which the stomach empties its contents very slowly 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.
306 studies on the registry are indexed under Gastroparesis; 67 are open to participants now.
This study's enrollment of 20 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 4 times a day for 8 weeks
Drug: Cisapride
Placebo one placebo tablet 4 times a day for 8 weeks
Drug: Placebo
one 10 mg tablet 4 times a day for 8 weeks
one placebo tablet 4 times a day for 8 weeks
The average change from baseline in Gastroparesis Cardinal Symptoms Index (GCSI) score
Time frame: At baseline (Week 0) up to 8 weeks
The number and type of adverse events reported
Time frame: From time of first dose to the last dose (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.