NCT00787891

Brief Summary

The purpose of the study is to access the effectiveness and safety of oral rabeprazole in the treatment of acid-related disorders in pediatric patients, focusing specifically on the manifestation of GERD (symptomatic and erosive types).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2009

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 10, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

October 11, 2012

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

2 years

First QC Date

November 6, 2008

Results QC Date

July 27, 2012

Last Update Submit

January 22, 2013

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

Gastroesophageal Reflux Disease (GERD)Erosive Gastroesophageal Reflux DiseaseUlcerative Gastroesophageal Reflux DiseaseEndoscopyPediatricsRabeprazole

Outcome Measures

Primary Outcomes (2)

  • The Percentage of Patients With Healing by Week 12 (Short-term Double-blind Treatment Phase)

    Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa.

    12 weeks

  • The Percentage of Patients With Healing by Week 36 (Double-blind Maintenance Treatment Phase)

    Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa.

    36 weeks

Secondary Outcomes (4)

  • The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Short-term Double-blind Treatment Phase)

    Baseline, Week 12

  • The Change From Baseline in the Total GERD Symptom and Severity Score (Short-term Double-blind Treatment Phase)

    Baseline, Week 12

  • The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Double-blind Maintenance Treatment Phase)

    Baseline, Week 36

  • The Change From Baseline in the Total GERD Symptom and Severity Score (Double-blind Maintenance Treatment Phase)

    Baseline, Week 36

Study Arms (2)

Rabeprazole 0.5 mg/kg

EXPERIMENTAL

rabeprazole 0.5mg/kg once daily for 12 weeks plus option for F/u another 24 weeks

Drug: rabeprazole

Rabeprazole 1.0 mg/kg

EXPERIMENTAL

rabeprazole 1.0 mg/kg once daily for 12 weeks plus option for F/u another 24 weeks

Drug: rabeprazole

Interventions

rabeprazoleDRUG

0.5mg/kg once daily for 12 weeks plus option for F/u another 24 weeks

Rabeprazole 0.5 mg/kg

Eligibility Criteria

Age1 Year - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • History of at least 1 Gastroesophageal Reflux Disease (GERD) symptom within 3 months of screening
  • Positive esophagogastroduodenoscopy
  • Signed informed consent
  • Female patients (if menstruating) must be practicing birth control

You may not qualify if:

  • Patients with history of esophagitis
  • Patients who have milk protein allergy
  • Patients who have taken Proton Pump Inhibitors or H2-blockers within 3 days
  • Patients who have taken sucralate or any medication that affects gastrointestinal motility
  • Patients with H. pylori
  • Patients with lab values outside the normal age appropriate range
  • Patients who have participated in another trial within 30 days before screening
  • Patients with allergies to Proton Pump Inhibitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Haddad I, Kierkus J, Tron E, Ulmer A, Hu P, Sloan S, Silber S, Leitz G. Efficacy and safety of rabeprazole in children (1-11 years) with gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr. 2013 Dec;57(6):798-807. doi: 10.1097/MPG.0b013e3182a4e718.

    PMID: 23863328DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
PORTFOLIO/CDT LEADER
Organization
Janssen R&D US
1 609 730-2548

Study Officials

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

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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2008

First Posted

November 10, 2008

Study Start

January 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 24, 2013

Results First Posted

October 11, 2012

Record last verified: 2013-01