A Phase 4 interventional study of Placebo and Cisapride in Gastroesophageal Reflux, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Terminated. Open to participants aged 1 Month to 18 Months. 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 compare the efficacy and tolerability of cisapride with placebo in infants and children with gastro-oesophageal reflux disease (GORD).
This is a double-blind (neither patient nor study staff will know the identity of the assigned treatment) study evaluate the effectiveness and safety of cisapride in patients with gastro-oesophageal reflux disease (GORD) (also referred to as gastroesophageal reflux disease [GERD[) compared to a placebo (a identical in appearance to cisapride but does not contain active drug). Patients will receive placebo or cisapride suspension at 0.2 mg/kg (volumn determined by patient weight) four times per day (q.i.d.) (15 minutes before feeding 3 times a day and at bedtime) orally (by mouth) for 8 weeks.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 6 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux 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 0.2 mg/kg suspension q.i.d.for 8 weeks.
Drug: Cisapride
Placebo Suspension identical in appearance to cisapride q.i.d. for 8 weeks.
Drug: Placebo
Suspension identical in appearance to cisapride q.i.d. for 8 weeks.
0.2 mg/kg suspension q.i.d.for 8 weeks.
Caregiver's assessment of infant pediatric GORD symptoms
Time frame: Up to 8 weeks (56 days)
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.