Phase 3
N=344
Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)
Gastroesophageal Reflux
Bottom Line
View on ClinicalTrials.gov: NCT00992589 ↗Enrolled (actual)
344
Serious AEs
4.6%
Results posted
May 2013
Primary outcome: Primary: Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward) — -0.8; -0.8; -1.6; -1.2 frequency of Regurgitation — p=0.168
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rabeprazole sodium 5 mg (Drug); Rabeprazole sodium 10 mg (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward) |
-0.8; -0.8; -1.6; -1.2 | 0.168 |
| PRIMARY Change From Baseline in Weight-for-Age Z-Score (Double-blind Phase/ Baseline Observation Carried Forward) |
0.11; 0.16; 0.11; 0.14 | 0.440 |
| PRIMARY Change From Baseline in I-GERQ-R Total Score (Double-blind Phase/ Baseline Observation Carried Forward) |
-3.6; -3.8; -4.1; -3.9 | 0.960 |
| PRIMARY Change From Baseline in in Weekly Average I-GERQ-DD Total Score (Double-blind Phase/ Baseline Observation Carried Forward) |
-1.9; -1.6; -2.1; -1.9 | 0.968 |
| SECONDARY The Daily Average Number of Episodes Related to Each Volume of Regurgitation During the Double-blind Treatment Period |
1.2; 1.1; 1.9; 0.8; 0.7; 1.0 | — |
| SECONDARY Change From Baseline in Weekly Average I-GERQ-DD Regurgitation Subscale Score (Double-blind Phase/ Last Observation Carried Forward) |
-0.8; -0.8; -1.0; -0.9 | 0.984 |
| SECONDARY Change From Baseline in Weekly Average I-GERQ-DD Discomfort Subscale Score (Double-blind Phase/ Last Observation Carried Forward) |
0.0; -0.1; -0.4; -0.2 | 0.479 |
| SECONDARY Change From Baseline in Weekly Average I-GERQ-DD Eating Behavior Subscale Score (Double-blind Phase/ Last Observation Carried Forward) |
-0.1; -0.1; -0.4; -0.3 | 0.498 |
Summary
The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with placebo in the treatment of gastrointestinal esophageal reflux disease (GERD) in infants 1 to 11 months of age.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of suspected GERD, symptomatic GERD, or endoscopically or histologically proven GERD, based on frequent vomiting or regurgitation, with at least 1 of the following: a) poor weight gain, or b) irritability, excessive crying or disturbed sleep that both the parent(s) and the doctor consider abnormal (but not due to colic)
- or c) refusal to eat even if hungry or arching of the back during meals
- weight 2.5 kg to 15.0 kg
- I-GERQ-R score >16
- Have only 1 caregiver in addition to the parent(s)
Exclusion Criteria
- History of confirmed acute life-threatening events due to GERD
- Known narrowing of the opening from the stomach to the small intestines
- Confirmed diagnosis of cow's milk allergy
- Have taken PPIs or H2-blockers (a class of drugs that inhibit stomach acid production) or any of several drugs that affect the normal movement of the digestive tract (caffeine, theophylline, antacids, erythromycin, and others) within 3 days before entering the study
- Have blood or urine test results that are well above or below the normal range for the infant
Data sourced from ClinicalTrials.gov (NCT00992589). 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.