A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease

Johnson & Johnson (J&J)

Status and phase

Terminated

Phase 4

Conditions

Gastroesophageal Reflux

Treatments

Drug: Cisapride

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01281553

CIS-INT-27

CR003952

Details and patient eligibility

About

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).

Full description

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.

Enrollment

6 patients

Sex

All

Ages

1 to 18 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of GORD based on protocol-specified characteristics
Failed the 1st of 5 stepwise treatments for GORD recommended by the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN)
Caregiver able to complete the I-GERQ-R questionnaire

Exclusion criteria

Protocol-specified respiratory conditions requiring previous or current treatment with oral or intravenous corticosteroids (prior and concurrent use of inhaled corticosteroids is acceptable)
Cause of vomiting/regurgitation other than GORD
Prior history of cisapride intake