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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00992589




Registration number
NCT00992589
Ethics application status
Date submitted
4/09/2009
Date registered
9/10/2009
Date last updated
22/05/2013

Titles & IDs
Public title
Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)
Scientific title
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Withdrawal Study to Evaluate the Safety and Efficacy of Delayed Release Rabeprazole in 1- to 11-Month-Old Pediatric Subjects With Symptomatic/Gastroesophageal Erosive Reflux Disease (GERD)
Secondary ID [1] 0 0
RABGRD3004
Secondary ID [2] 0 0
CR014836
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal Reflux 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rabeprazole sodium 5 mg
Treatment: Drugs - Rabeprazole sodium 10 mg
Treatment: Drugs - Placebo

Experimental: Rabeprazole sodium 5 mg -

Experimental: Rabeprazole sodium 10 mg -

Placebo comparator: Placebo -


Treatment: Drugs: Rabeprazole sodium 5 mg
Rabeprazole Sodium 5 mg capsules once daily in the morning.

Treatment: Drugs: Rabeprazole sodium 10 mg
Rabeprazole Sodium 10 mg capsules once daily in the morning.

Treatment: Drugs: Placebo
Matching placebo capsules once daily in the morning.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward)
Timepoint [1] 0 0
Baseline, Week 8
Primary outcome [2] 0 0
Change From Baseline in Weight-for-Age Z-Score (Double-blind Phase/ Baseline Observation Carried Forward)
Timepoint [2] 0 0
Baseline, Week 8
Primary outcome [3] 0 0
Change From Baseline in I-GERQ-R Total Score (Double-blind Phase/ Baseline Observation Carried Forward)
Timepoint [3] 0 0
Baseline, Week 8
Primary outcome [4] 0 0
Change From Baseline in in Weekly Average I-GERQ-DD Total Score (Double-blind Phase/ Baseline Observation Carried Forward)
Timepoint [4] 0 0
Baseline, Week 8
Secondary outcome [1] 0 0
The Daily Average Number of Episodes Related to Each Volume of Regurgitation During the Double-blind Treatment Period
Timepoint [1] 0 0
Baseline, Week 8
Secondary outcome [2] 0 0
Change From Baseline in Weekly Average I-GERQ-DD Regurgitation Subscale Score (Double-blind Phase/ Last Observation Carried Forward)
Timepoint [2] 0 0
Baseline, Week 8
Secondary outcome [3] 0 0
Change From Baseline in Weekly Average I-GERQ-DD Discomfort Subscale Score (Double-blind Phase/ Last Observation Carried Forward)
Timepoint [3] 0 0
Baseline, Week 8
Secondary outcome [4] 0 0
Change From Baseline in Weekly Average I-GERQ-DD Eating Behavior Subscale Score (Double-blind Phase/ Last Observation Carried Forward)
Timepoint [4] 0 0
Baseline, Week 8

Eligibility
Key inclusion criteria
* Diagnosis of suspected GERD, symptomatic GERD, or endoscopically or histologically proven GERD, based on frequent vomiting or regurgitation, with at least 1 of the following: a) poor weight gain, or b) irritability, excessive crying or disturbed sleep that both the parent(s) and the doctor consider abnormal (but not due to colic)
* or c) refusal to eat even if hungry or arching of the back during meals
* weight 2.5 kg to 15.0 kg
* I-GERQ-R score >16
* Have only 1 caregiver in addition to the parent(s)
Minimum age
1 Month
Maximum age
11 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of confirmed acute life-threatening events due to GERD
* Known narrowing of the opening from the stomach to the small intestines
* Confirmed diagnosis of cow's milk allergy
* Have taken PPIs or H2-blockers (a class of drugs that inhibit stomach acid production) or any of several drugs that affect the normal movement of the digestive tract (caffeine, theophylline, antacids, erythromycin, and others) within 3 days before entering the study
* Have blood or urine test results that are well above or below the normal range for the infant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2011
Sample size
Target
Accrual to date
Final
344
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Garran
Recruitment hospital [2] 0 0
- Herston
Recruitment hospital [3] 0 0
- Kogarah
Recruitment hospital [4] 0 0
- Parkville
Recruitment hospital [5] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
- Garran
Recruitment postcode(s) [2] 0 0
- Herston
Recruitment postcode(s) [3] 0 0
- Kogarah
Recruitment postcode(s) [4] 0 0
- Parkville
Recruitment postcode(s) [5] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arizona
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Arkansas
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California
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Colorado
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Florida
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Georgia
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Illinois
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Indiana
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Kentucky
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Louisiana
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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Tennessee
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Texas
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Virginia
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West Virginia
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Belgium
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Antwerpen
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Belgium
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Brussel
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Belgium
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Leuven
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Bulgaria
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Pleven
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Denmark
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Odense
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Hungary
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Budapest
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Hungary
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Békéscsaba
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Hungary
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Gyulai Ut 18
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Hungary
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Gyõr
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Miskolc
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Nyiregyhaza
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Hungary
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Pecs
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Hungary
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Szombathely
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Hungary
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Veszprem
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Hungary
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Veszprém
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petach Tikvah
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Israel
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Tiberias
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Netherlands
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Amsterdam
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Netherlands
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Nijmegen
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Netherlands
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Zwolle
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Poland
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Bialystok
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Bydgoszcz N/A
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Czestochowa
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Rzeszow N/A
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Rzeszow
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Torun
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Warszawa
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South Africa
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Durbanville
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South Africa
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Durban
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South Africa
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Panorama
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South Africa
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Wynberg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eisai Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with placebo in the treatment of gastrointestinal esophageal reflux disease (GERD) in infants 1 to 11 months of age.
Trial website
https://clinicaltrials.gov/study/NCT00992589
Trial related presentations / publications
Sharp WG, Stubbs KH, Adams H, Wells BM, Lesack RS, Criado KK, Simon EL, McCracken CE, West LL, Scahill LD. Intensive, Manual-based Intervention for Pediatric Feeding Disorders: Results From a Randomized Pilot Trial. J Pediatr Gastroenterol Nutr. 2016 Apr;62(4):658-63. doi: 10.1097/MPG.0000000000001043.
Hussain S, Kierkus J, Hu P, Hoffman D, Lekich R, Sloan S, Treem W. Safety and efficacy of delayed release rabeprazole in 1- to 11-month-old infants with symptomatic GERD. J Pediatr Gastroenterol Nutr. 2014 Feb;58(2):226-36. doi: 10.1097/MPG.0000000000000195.
Treem W, Hu P, Sloan S. Normal and proton pump inhibitor-mediated gastrin levels in infants 1 to 11 months old. J Pediatr Gastroenterol Nutr. 2013 Oct;57(4):520-6. doi: 10.1097/MPG.0b013e31829b6914.
Public notes

Contacts
Principal investigator
Name 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Address 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00992589