NCT01281553

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_4

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2011

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

First QC Date

January 20, 2011

Last Update Submit

January 20, 2011

Conditions

Gastroesophageal Reflux

Keywords

Cisapride (PREPULSID)PlaceboGastroesophageal Reflux Disease (GERD)Gastro-oesophageal Reflux Disease (GORD)

Outcome Measures

Primary Outcomes (1)

  • Caregiver's assessment of infant pediatric GORD symptoms

    Up to 8 weeks (56 days)

Secondary Outcomes (1)

  • The number and type of adverse events reported

    From time of first dose to the last dose (up to 8 weeks)

Study Arms (2)

001

EXPERIMENTAL

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

Drug: Cisapride

002

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

PlaceboDRUG

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

002
CisaprideDRUG

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

001

Eligibility Criteria

Age1 Month - 18 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Cisapride

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 20, 2011

First Posted

January 24, 2011

Study Start

September 1, 2003

Study Completion

October 1, 2003

Last Updated

January 24, 2011

Record last verified: 2011-01