Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux
Intervention: Rabeprazole sodium 5 mg (Drug); Rabeprazole sodium 10 mg (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s): Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
Clinical Details
Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Withdrawal Study to Evaluate the Safety and Efficacy of Delayed Release Rabeprazole in 1- to 11-Month-Old Pediatric Subjects With Symptomatic/Gastroesophageal Erosive Reflux Disease (GERD)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward)Change From Baseline in Weight-for-Age Z-Score (Double-blind Phase/ Baseline Observation Carried Forward) Change From Baseline in I-GERQ-R Total Score (Double-blind Phase/ Baseline Observation Carried Forward) Change From Baseline in in Weekly Average I-GERQ-DD Total Score (Double-blind Phase/ Baseline Observation Carried Forward)
Secondary outcome: The Daily Average Number of Episodes Related to Each Volume of Regurgitation During the Double-blind Treatment PeriodChange From Baseline in Weekly Average I-GERQ-DD Regurgitation Subscale Score (Double-blind Phase/ Last Observation Carried Forward) Change From Baseline in Weekly Average I-GERQ-DD Discomfort Subscale Score (Double-blind Phase/ Last Observation Carried Forward) Change From Baseline in Weekly Average I-GERQ-DD Eating Behavior Subscale Score (Double-blind Phase/ Last Observation Carried Forward)
Detailed description:
Rabeprazole sodium belongs to the class of drugs known as proton pump inhibitors, which
suppress gastric acid secretion. The drug is approved in the United States for the treatment
of adults with GERD and other acid-related gastrointestinal disorders, and has been studied
in adolescents (older than 12 years of age) with results similar to those in adults.
However, the drug has not been studied in children under the age of 12 years. This study
focuses on the efficacy and safety of rabeprazole sodium in infants aged 1 to 11 months, the
pediatric group in which the prevalence of GERD-related symptoms is the greatest. This is a
multicenter, double-blind, randomized, placebo-controlled, parallel-group withdrawal study
to compare the efficacy and safety of 2 doses (0. 5 mg/kg or 1. 0 mg/kg daily) of rabeprazole
with placebo in the treatment of infants aged 1 to 11 months who have a diagnosis of
suspected GERD, symptomatic GERD, or endoscopically or histologically proven GERD. The study
consists of 3 study periods: a screening period of up to 10 days, an open-label treatment
period of up to 3 weeks, and a 5-week double-blind treatment period. Patients who have been
receiving GERD therapy before screening will have their GERD therapy discontinued for 3 days
before entering the open-label treatment period. Patients who have a positive clinical
response according to the Clinical Global Impressions - Improvement (CGI-I) scale at the end
of the first or second week of the open-label treatment period will enter the double-blind
treatment period; those who do not will be withdrawn from the study. A parent, legal
guardian, or other individual experienced in the care of the infant will be the primary
caregiver, who is responsible for the daily and weekly assessments and study drug
administration. Efficacy assessments consist of the Infant Gastroesophageal Reflux
Questionnaire Revised (I GERQ-R) total score, the Infant Gastroesophageal Reflux
Questionnaire-Daily Diary (I GERQ-DD) total score, the CGI-I, the Global Treatment
Satisfaction Score, and the weight-for-age Z-score. Safety assessments include monitoring of
concomitant therapies and adverse events throughout the study; clinical laboratory testing
(hematology, clinical chemistry, urinalysis), measurement of vital signs (pulse and
respiratory rate, blood pressure, temperature); and physical examination including length
and weight. The study hypothesis is that rabeprazole sodium is superior to placebo in the
treatment of GERD in infants aged 1 to 11 months. Rabeprazole sodium capsule(s) by mouth
once a day, 10. 0 milligram (mg)/kilogram (kg) for up to 3 weeks during the open-label
treatment period and either 5. 0 mg/kg or 10. 0 mg/kg during the 5-week double-blind treatment
period. To give the study drug to the infants, the contents of the capsule(s) are sprinkled
onto a small amount of soft food or, as needed, the contents of the capsule(s) may be given
in a small amount (5 milliliter [mL]) of infant formula or expressed breast milk.
Eligibility
Minimum age: 1 Month.
Maximum age: 11 Months.
Gender(s): Both.
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
Locations and Contacts
Garran, Australia
Herston, Australia
Kogarah, Australia
Parkville, Australia
Sydney, Australia
Antwerpen, Belgium
Brussel, Belgium
Leuven, Belgium
Pleven, Bulgaria
Odense, Denmark
Budapest, Hungary
Békéscsaba, Hungary
Gyulai Ut 18, Hungary
Gyõr, Hungary
Miskolc, Hungary
Nyiregyhaza, Hungary
Pecs, Hungary
Szombathely, Hungary
Veszprem, Hungary
Veszprém, Hungary
Haifa, Israel
Jerusalem, Israel
Petach Tikvah, Israel
Petach Tikva, Israel
Ramat Gan, Israel
Tiberias, Israel
Amsterdam, Netherlands
Nijmegen, Netherlands
Zwolle, Netherlands
Bialystok, Poland
Bydgoszcz N/A, Poland
Bydgoszcz, Poland
Czestochowa, Poland
Rzeszow N/A, Poland
Rzeszow, Poland
Torun, Poland
Warszawa, Poland
Durbanville, South Africa
Durban, South Africa
Panorama, South Africa
Wynberg, South Africa
Birmingham, Alabama, United States
Columbiana, Alabama, United States
Dothan, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
Phoenix, Arizona, United States
Bentonville, Arkansas, United States
Orange, California, United States
Centennial, Colorado, United States
Thornton, Colorado, United States
Maitland, Florida, United States
Miami, Florida, United States
Augusta, Georgia, United States
Park Ridge, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Owensboro, Kentucky, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Flint, Michigan, United States
St. Paul, Minnesota, United States
Jackson, Mississippi, United States
Bridgeton, Missouri, United States
Mays Landing, New Jersey, United States
Valhalla, New Jersey, United States
Bronx, New York, United States
Buffalo, New York, United States
Utica, New York, United States
Charlotte, North Carolina, United States
Toledo, Ohio, United States
Youngstown, Ohio, United States
Gresham, Oregon, United States
Hershey, Pennsylvania, United States
Chattanooga, Tennessee, United States
Kingsport, Tennessee, United States
Dallas, Texas, United States
Laredo, Texas, United States
San Antonio, Texas, United States
Tomball, Texas, United States
Fairfax, Virginia, United States
Huntington, West Virginia, United States
Additional Information
Starting date: November 2009
Last updated: April 16, 2013
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