Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)
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)
2 other identifiers
interventional
344
10 countries
81
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2009
81 active sites
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
First Submitted
Initial submission to the registry
September 4, 2009
CompletedFirst Posted
Study publicly available on registry
October 9, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
May 22, 2013
CompletedMay 22, 2013
April 1, 2013
2 years
September 4, 2009
November 15, 2012
April 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward)
Baseline, Week 8
Change From Baseline in Weight-for-Age Z-Score (Double-blind Phase/ Baseline Observation Carried Forward)
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).
Baseline, Week 8
Change From Baseline in I-GERQ-R Total Score (Double-blind Phase/ Baseline Observation Carried Forward)
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.
Baseline, Week 8
Change From Baseline in in Weekly Average I-GERQ-DD Total Score (Double-blind Phase/ Baseline Observation Carried Forward)
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.
Baseline, Week 8
Secondary Outcomes (4)
The Daily Average Number of Episodes Related to Each Volume of Regurgitation During the Double-blind Treatment Period
Baseline, Week 8
Change From Baseline in Weekly Average I-GERQ-DD Regurgitation Subscale Score (Double-blind Phase/ Last Observation Carried Forward)
Baseline, Week 8
Change From Baseline in Weekly Average I-GERQ-DD Discomfort Subscale Score (Double-blind Phase/ Last Observation Carried Forward)
Baseline, Week 8
Change From Baseline in Weekly Average I-GERQ-DD Eating Behavior Subscale Score (Double-blind Phase/ Last Observation Carried Forward)
Baseline, Week 8
Study Arms (3)
Rabeprazole sodium 5 mg
EXPERIMENTALRabeprazole sodium 10 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Rabeprazole Sodium 5 mg capsules once daily in the morning.
Rabeprazole Sodium 10 mg capsules once daily in the morning.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (81)
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Birmingham, Alabama, United States
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Columbiana, Alabama, United States
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Dothan, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Bentonville, Arkansas, United States
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Orange, California, United States
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Centennial, Colorado, United States
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Thornton, Colorado, United States
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Maitland, Florida, United States
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Miami, Florida, United States
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Augusta, Georgia, United States
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Park Ridge, Illinois, United States
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Indianapolis, Indiana, United States
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Louisville, Kentucky, United States
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Owensboro, Kentucky, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
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Flint, Michigan, United States
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Saint Paul, Minnesota, United States
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Jackson, Mississippi, United States
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Bridgeton, Missouri, United States
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Mays Landing, New Jersey, United States
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Valhalla, New Jersey, United States
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Buffalo, New York, United States
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The Bronx, New York, United States
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Utica, New York, United States
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Charlotte, North Carolina, United States
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Toledo, Ohio, United States
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Youngstown, Ohio, United States
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Gresham, Oregon, United States
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Hershey, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Kingsport, Tennessee, United States
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Dallas, Texas, United States
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Laredo, Texas, United States
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San Antonio, Texas, United States
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Tomball, Texas, United States
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Fairfax, Virginia, United States
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Huntington, West Virginia, United States
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Garran, Australia
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Herston, Australia
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Kogarah, Australia
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Parkville, Australia
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Sydney, Australia
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Antwerp, Belgium
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Brussels, Belgium
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Leuven, Belgium
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Pleven, Bulgaria
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Odense, Denmark
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Békéscsaba, Hungary
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Budapest, Hungary
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Gyõr, Hungary
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Gyulai Ut 18, Hungary
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Miskolc, Hungary
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Nyíregyháza, Hungary
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Pécs, Hungary
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Szombathely, Hungary
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Veszprém, Hungary
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Haifa, Israel
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Jerusalem, Israel
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Petach Tikvah, Israel
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Petah Tikva, Israel
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Ramat Gan, Israel
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Tiberias, Israel
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Amsterdam, Netherlands
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Nijmegen, Netherlands
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Zwolle, Netherlands
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Bialystok, Poland
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Bydgoszcz, Poland
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Częstochowa, Poland
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Rzeszów, Poland
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Torun, Poland
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Warsaw, Poland
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Durban, South Africa
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Durbanville, South Africa
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Panorama, South Africa
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Wynberg, South Africa
Related Publications (3)
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.
PMID: 26628445DERIVEDHussain 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.
PMID: 24121146DERIVEDTreem 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.
PMID: 23689261DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- PORTFOLIO/CDT LEADER
- Organization
- Janssen R&D US
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
September 4, 2009
First Posted
October 9, 2009
Study Start
November 1, 2009
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
May 22, 2013
Results First Posted
May 22, 2013
Record last verified: 2013-04