Phase 3
N=127
A Study of the Safety and Effectiveness of Rabeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients
Gastroesophageal Reflux Disease (GERD)
Bottom Line
View on ClinicalTrials.gov: NCT00787891 ↗Enrolled (actual)
127
Serious AEs
5.8%
Results posted
Oct 2012
Primary outcome: Primary: The Percentage of Patients With Healing by Week 12 (Short-term Double-blind Treatment Phase) — 78; 83 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- rabeprazole (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Patients With Healing by Week 12 (Short-term Double-blind Treatment Phase) |
78; 83 | — |
| PRIMARY The Percentage of Patients With Healing by Week 36 (Double-blind Maintenance Treatment Phase) |
92; 88 | — |
| SECONDARY The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Short-term Double-blind Treatment Phase) |
-1.3; -1.0 | — |
| SECONDARY The Change From Baseline in the Total GERD Symptom and Severity Score (Short-term Double-blind Treatment Phase) |
-11.5; -8.5 | — |
| SECONDARY The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Double-blind Maintenance Treatment Phase) |
0.2; 0.2 | — |
| SECONDARY The Change From Baseline in the Total GERD Symptom and Severity Score (Double-blind Maintenance Treatment Phase) |
-2.9; -1.4 | — |
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 GERD (symptomatic and erosive types).
Eligibility Criteria
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT00787891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.