Status:
COMPLETED
Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Eisai Inc.
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
1-11 years
Phase:
PHASE3
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 th...
Detailed Description
Rabeprazole sodium belongs to the class of drugs known as proton pump inhibitors, which suppress gastric acid secretion. The drug is approved in the United States for the treatment of adults with GERD...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT00992589
Start Date
November 1 2009
End Date
November 1 2011
Last Update
May 22 2013
Active Locations (81)
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Birmingham, Alabama, United States
2
Columbiana, Alabama, United States
3
Dothan, Alabama, United States
4
Huntsville, Alabama, United States