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

Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of R051619 (Cisapride Oral Suspension 0.2 mg/kg q.i.d.) for the Treatment of Symptomatic Gastro-Oesophageal Reflux Disease (GORD) in Infants and Children

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01281553

Enrollment

Registered

2011-01-24

Start date

2003-09-30

Completion date

2003-10-31

Last updated

2011-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux

Keywords

Cisapride (PREPULSID), Placebo, Gastroesophageal Reflux Disease (GERD), Gastro-oesophageal Reflux Disease (GORD)

Brief summary

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).

Detailed 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.

Interventions

DRUGPlacebo

Suspension identical in appearance to cisapride q.i.d. for 8 weeks.

DRUGCisapride

0.2 mg/kg suspension q.i.d.for 8 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Months to 18 Months

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

Design outcomes

Primary

Measure	Time frame
Caregiver's assessment of infant pediatric GORD symptoms	Up to 8 weeks (56 days)

Secondary

Measure	Time frame
The number and type of adverse events reported	From time of first dose to the last dose (up to 8 weeks)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026