Status:
COMPLETED
A Study of the Safety and Effectiveness of Rabeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Eisai Inc.
Conditions:
Gastroesophageal Reflux Disease (GERD)
Eligibility:
All Genders
1-11 years
Phase:
PHASE3
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 G...
Detailed Description
This is a randomized, double-blind study that consists of two parts. In Part 1, the study will consist of 3 phases: a 14-day screening phase, a double-blind treatment phase of 12 weeks comparing two d...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00787891
Start Date
January 1 2009
End Date
January 1 2011
Last Update
January 24 2013
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