At a glance
ClinicalIndex Comparison Record- ✓Age 12–16 years with clinical diagnosis, suspected, or endoscopically proven GERD
- ✓Able to swallow study tablet intact; ability confirmed at screening
- ✓Able to discontinue PPIs and H2 blockers for 3 days prior to dosing (cimetidine 7 days) and tolerate 2-week PPI-free period at end of treatment
- ✓Children with stable asthma/reactive airways disease on stable treatment regimens are eligible
- ✕Significant hepatic, renal, respiratory, endocrine, immune, infectious, hematologic, neurologic, psychiatric, or cardiovascular abnormalities that would interfere with study conduct or patient health
- ✕History of primary esophageal motility disorders or systemic conditions affecting the esophagus (e.g., scleroderma, esophageal infections)
- ✕History of eosinophilic esophagitis, persistent milk protein allergy, or allergic gastroenteropathy; current H. pylori infection or peptic ulcers
- ✕History of definitive acid-lowering surgery, previous esophageal surgery, or esophageal stricture
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy of Rabeprazole in the Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients
In Brief
A Phase 2 clinical trial evaluating rabeprazole sodium for Gastroesophageal Reflux Disease. Completed, enrolled 111 participants across 25 sites.
Detailed Summary
The primary objective of this study is to collect safety information on rabeprazole 10 mg and 20 mg in the treatment of gastroesophageal reflux disease (GERD) in children aged 12 to 16 years. The secondary objectives are to assess the efficacy of rabeprazole on the improvement of the symptoms of GERD and to explore the relationship of symptom relief to dose received, based on symptom frequency and severity, antacid use, and quality of life (QOL) measures.
Study Details
Timeline
Interventions
administered orally and once daily to patients randomized to receive either 10 mg or 20 mg.