A Study of the Safety and Effectiveness of Rabeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Gastroesophageal Reflux Disease (GERD)
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
History of at least 1 GERD symptom within 3 months of screening
Positive esophagogastroduodenoscopy
Signed informed consent
Female patients (if menstruating) must be practicing birth control
Exclusion Criteria
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the efficacy (endoscopic/histological healing) and safety of 2 dose levels (0.5 mg/kg and 1.0 mg/kg) of a pediatric bead formulation in a 12 week design followed by long-term safety and efficacy assessment in a 24-week maintenance study.Timepoint: Evaluate the efficacy (endoscopic/histological healing) and safety of 2 dose levels (0.5 mg/kg and 1.0 mg/kg) of a pediatric bead formulation in a 12 week design followed by long-term safety and efficacy assessment in a 24-week maintenance study.
- Secondary Outcome Measures
Name Time Method Evaluate changes from baseline of endoscopic and histological grade, the percentage of patients with improvement in pH>4; changes in weekly average GERD scores and symptomsTimepoint: Evaluate changes from baseline of endoscopic and histological grade, the percentage of subjects with improvement in pH>4; changes in weekly average GERD scores & symptoms