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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
6
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)
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