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Cisapride in Pediatric GORD
NCT01281553Phase 4
Key facts
- Status
- Terminated
- Start
- Sep 2003
- Sponsor
- Johnson & Johnson
- Modality
- Small Molecules
- Drugs
- cisapride
- Conditions
- gastroesophageal reflux disease (GERD)
01
Overview
Phase 4, randomised, double-blind trial in gastroesophageal reflux disease (GERD) comparing Cisapride Arm with Placebo Arm (2 arms). Primary endpoint: Caregiver's assessment of infant pediatric GORD symptoms at 8 weeks. Started Sep 2003; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Cisapride Arm
Cisapride 0.2 mg/kg q.i.d.
Placebo Arm
Placebo suspension q.i.d.
03
Who it enrols
Infants and children with GORD who have failed the first of 5 stepwise treatments recommended by ESPGHAN.
04
Endpoints
Primary
Caregiver's assessment of infant pediatric GORD symptoms
Secondary
Number and type of adverse events reported
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