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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 Period

Change 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

Page last updated: August 20, 2015

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