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

Johnson & Johnson (J&J) logo

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

6 participants in 2 patient groups, including a placebo group

001
Experimental group
Description:
Cisapride 0.2 mg/kg suspension q.i.d.for 8 weeks.
Treatment:
Drug: Cisapride
002
Placebo Comparator group
Description:
Placebo Suspension identical in appearance to cisapride q.i.d. for 8 weeks.
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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