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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)
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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)
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Secondary ID [1]
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RABGRD3004
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Secondary ID [2]
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CR014836
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal Reflux
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward)
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Assessment method [1]
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Timepoint [1]
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Baseline, Week 8
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Primary outcome [2]
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Change From Baseline in Weight-for-Age Z-Score (Double-blind Phase/ Baseline Observation Carried Forward)
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Assessment method [2]
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Body weight was measured with the participant unclothed and before a feeding during each office visit. In the analysis of weight data, weight will be transformed to the weight-for-age Z-score using World Health Organization Child Growth Standards, taking into account the infant's age and gender (Borghi E, 2006).
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Timepoint [2]
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Baseline, Week 8
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Primary outcome [3]
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Change From Baseline in I-GERQ-R Total Score (Double-blind Phase/ Baseline Observation Carried Forward)
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Assessment method [3]
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The Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R) is a 12-item questionnaire that is completed by the primary caregiver at every office or telephonic visit. It has a weekly recall and the items cover the frequency, amount and discomfort attributed to spit-up, refusal or stopping feeding, crying and fussing, hiccups, arching back and stopping breathing or changing color. The total score is calculated as the sum of all 12 scores for the individual questions, and ranges from 0 to 42. A higher value indicates a worse outcome.
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Timepoint [3]
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Baseline, Week 8
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Primary outcome [4]
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Change From Baseline in in Weekly Average I-GERQ-DD Total Score (Double-blind Phase/ Baseline Observation Carried Forward)
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Assessment method [4]
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The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the participant has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. Each of the 9 items will be assigned a numeric score. The total score will be calculated as the sum of all 9 items, and ranges from 0 to 37. A higher value indicates a worse outcome.
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Timepoint [4]
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Baseline, Week 8
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Secondary outcome [1]
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The Daily Average Number of Episodes Related to Each Volume of Regurgitation During the Double-blind Treatment Period
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Assessment method [1]
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Timepoint [1]
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Baseline, Week 8
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Secondary outcome [2]
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Change From Baseline in Weekly Average I-GERQ-DD Regurgitation Subscale Score (Double-blind Phase/ Last Observation Carried Forward)
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Assessment method [2]
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The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the participant has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Regurgitation subscale will be calculated as the sum of the 3 questions regarding regurgitation (Questions 1, 2, 3) and will range from 0 to 13. For each subscale score, a higher value indicates a worse outcome.
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Timepoint [2]
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Baseline, Week 8
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Secondary outcome [3]
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Change From Baseline in Weekly Average I-GERQ-DD Discomfort Subscale Score (Double-blind Phase/ Last Observation Carried Forward)
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Assessment method [3]
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The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the subject has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Discomfort subscale score will be calculated as the sum of the 3 questions regarding discomfort (Questions, 7, 8, 9) and will range from 0 to 12. For each subscale score, a higher value indicates a worse outcome.
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Timepoint [3]
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Baseline, Week 8
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Secondary outcome [4]
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Change From Baseline in Weekly Average I-GERQ-DD Eating Behavior Subscale Score (Double-blind Phase/ Last Observation Carried Forward)
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Assessment method [4]
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The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the subject has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Eating Behavior subscale score will be calculated as the sum of the 3 questions regarding eating behavior (Questions 4, 5, 6) and will range from 0 to 12. For each subscale score, a higher value indicates a worse outcome.
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Timepoint [4]
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Baseline, Week 8
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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)
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Minimum age
1
Month
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Maximum age
11
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2011
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Sample size
Target
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Accrual to date
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Final
344
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Garran
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- Herston
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- Kogarah
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- Parkville
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- Sydney
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- Garran
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- Herston
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- Kogarah
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- Parkville
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- Sydney
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Address
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Eisai Inc.
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00992589
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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.
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Public notes
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Contacts
Principal investigator
Name
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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
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Address
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00992589
Download to PDF