Objective: Evaluate the efficacy and safety of rabeprazole in children, 1 to 11 years old, with endoscopically/histologically proven gastroesophageal reflux disease (GERD).
Methods: Children were randomized to 0.5- or 1.0-mg/kg rabeprazole granule formulation for 12 weeks. The dose was further determined by weight: children 6 to 14.9 kg (low-weight cohort) received 5 or 10 mg and children ≥15 kg (high-weight cohort) received 10 or 20 mg. The primary endpoint was endoscopic/histologic healing at week 12 (defined as grade 0 on the Hetzel-Dent classification scale and/or grade 0 on the Histological Features of Reflux Esophagitis scale).
Results: Overall, 81% (87/108) achieved endoscopic/histologic healing at week 12 with higher healing in the low-weight cohort (82% [5-mg dose], 94% [10-mg dose]) compared with high-weight cohort (76% [10-mg dose], 78% [20-mg dose]). There was a significant (P < 0.001) decrease in the mean Total GERD Symptoms and Severity score from 19.7 points (baseline) to 8.6 points (week 12), with 26% fewer children reporting GERD symptoms at week 12. The average frequency of symptoms per child decreased from 7.7 (week 1) to 4.7 (week 12). The GERD Symptom Relief score showed that 71% of children felt better, 81% were rated “good to excellent” on the Global Treatment Satisfaction scale by the investigator; 77% were rated “good to excellent” on the Clinical Global Impressions-Improvement scale by the parent/caregiver. The most common (>10%) treatment-emergent adverse events included cough and vomiting (14% each), abdominal pain (12%), and diarrhea (11%).
Conclusions: Rabeprazole was effective and safe in 1- to 11-year-old children with GERD.
*Pediatric & Adolescent Gastroenterology & Nutrition, Youngstown, OH
†Children's Memorial Health Institute, Warsaw, Poland
‡Geisinger Medical Center Clinic, Wilkes Barre, PA
§Gastrointestinal Associates, Jackson, MS
||Janssen Research & Development, LLC, Titusville, NJ.
Address correspondence and reprint requests to Ibrahim Haddad, MD, Pediatric & Adolescent Gastroenterology & Nutrition, 8560 South Avenue #3, Youngstown, OH 44514 (e-mail: firstname.lastname@example.org).
Received 15 January, 2013
Accepted 11 July, 2013
This study was financially supported by funding from Janssen Research & Development, LLC (previously known as Johnson & Johnson Pharmaceutical Research & Development, LLC) and Eisai Medical Research, Inc. The sponsors also provided a formal review of this manuscript.
http://www.clinicaltrials.gov registration number: NCT00787891.
The study results were presented at Digestive Disease Week, May 7–10, 2011, Chicago, IL.
G.L., P.H., S. Sloan, and S. Silber are employees of Janssen Research & Development, LLC. The other authors report no conflicts of interest.