A Study of the Safety and Effectiveness of Rabeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients.

Condition(s) targeted: GERD; Gastroesophageal Reflux Disease

Intervention: rabeprazole (Drug); rabeprazole (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

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).

Official title: A Multi-Center, Double-Blind, Parallel-Group Study to Evaluate Short-Term Safety and Efficacy and Lont-Term Maintenance of Two Dose Levels of Rabeprazole Sodium Delayed-Release Pediatric Bead Formulation in 1- to 11-Year Old Pediatric Subjects With Endoscopically Proven GERD

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Evaluate the efficacy (endoscopic/histological healing) and safety of 2 dose levels (0.5 mg/kg and 1.0 mg/kg) of a pediatric bead formulation in a 12 week design followed by long-term safety and efficacy assessment in a 24-week maintenance.

Secondary outcome: Evaluate changes from baseline of endoscopic and histological grade, the percentage of patients with improvement in pH>4; changes in weekly average GERD scores and symptoms

Detailed description: This is a randomized, double-blind study that consists of two parts. In Part 1, the study will consist of 3 phases: a 14-day screening phase, a double-blind treatment phase of 12 weeks comparing two doses of study drug (0. 5 mg/kg or 1. 0 mg/kg groups based on patient's body weight), and an end-of-study or early withdrawal phase followed by Part 2, which consists a of double-blind treatment continuation for patients who have achieved healing during the short-term double-blind treatment phase. The double-blind maintenance treatment phase lasts for not more than 24 weeks and is concluded by an end-of-study/early withdrawal visit. During Part 1, patients will be screened and the diagnosis of erosive and non-erosive GERD will be made based on clinical symptoms and confirmed by endoscopy/histology after a biopsy. Patients enrolled in the study will receive study drug once daily for 12 weeks. Each day, the parent/caregiver will record the presence and severity of pre-specified GERD symptoms. At Weeks 4 and 8, the investigator will evaluate the response to treatment by assessment of the GERD symptoms. At Week 12, the investigator will perform an endoscopy of the esophagus with a biopsy to confirm that histological healing has occurred. If a patient continues, additional study drug will be dispensed (at the same dose taken during the short-term double-blind treatment phase) and the patient will be scheduled to return every 8 weeks until study drug is discontinued at Week 24 (Part 2) of the double-blind maintenance treatment phase. At the final visit of the maintenance treatment phase Week 24 (Part 2), assessments including an endoscopy of the esophagus with a biopsy be performed for each patient. Assessments of effectiveness include endoscopic and histological grading of biopsy samples, GERD symptom and severity score (symptoms and severity rated daily by the parent/caregiver in an electronic diary), overall GERD symptom relief, Clinical Global Impression of Improvement (CGI-I) score, and the Global Treatment Satisfaction Score. Safety assessments will include the monitoring of concomitant therapies and adverse events throughout the study, clinical laboratory testing (including hematology, clinical chemistry, urinalysis), vital signs, and physical examination including height, weight, and Tanner staging.

Oral rabeprazole 2. 5 capsules or 5 mg capsules, given once daily at a dose of 0. 5 mg/kg or 1. 0 mg/kg; short-term treatment phase is 12 weeks; long-term maintenance treatment phase is 24 weeks.

Minimum age: 1 Year. Maximum age: 11 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- History of at least 1 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

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

Antwerpen 2020, Belgium; Not yet recruiting

Brussels 1200, Belgium; Not yet recruiting

Antwerpen 2018, Belgium; Not yet recruiting

Kÿbenhavn Y 2100, Denmark; Recruiting

Odense 5000, Denmark; Not yet recruiting

Viborg 8800, Denmark; Not yet recruiting

Bron 69500, France; Not yet recruiting

Lille 75674, France; Not yet recruiting

Tours 37000, France; Not yet recruiting

Lille 59000, France; Not yet recruiting

Lille, France; Not yet recruiting

Bordeaux 33076, France; Not yet recruiting

Budapest, Hungary; Not yet recruiting

Veszprem H-8200, Hungary; Not yet recruiting

Gyõr 9023, Hungary; Not yet recruiting

Békéscsaba 5600, Hungary; Not yet recruiting

Sopron 9400, Hungary; Not yet recruiting

Visakhapatnam 530002, India; Not yet recruiting

Indore 452001, India; Not yet recruiting

Tiberias 15208, Israel; Not yet recruiting

Petach Tikva 49202, Israel; Not yet recruiting

Holon 58 100, Israel; Not yet recruiting

Haifa 31096, Israel; Not yet recruiting

Jerusalem 91031, Israel; Not yet recruiting

Ramat Gan 52621, Israel; Not yet recruiting

Brussel 1090, Netherlands; Not yet recruiting

Nijmegen 6525 GA, Netherlands; Not yet recruiting

Amsterdam, Netherlands; Not yet recruiting

Bialystok 15-274, Poland; Not yet recruiting

Warszawa 01-184, Poland; Not yet recruiting

Kraków, Poland; Not yet recruiting

Wroclaw 50-369, Poland; Not yet recruiting

Czestochowa 42-200, Poland; Not yet recruiting

Wroclaw 51-124, Poland; Not yet recruiting

Bydgoszcz 85-094, Poland; Not yet recruiting

Torun 87-100, Poland; Not yet recruiting

Rzeszow Poland 35-301, Poland; Not yet recruiting

Lodz 91-738, Poland; Not yet recruiting

Warszawa 00000, Poland; Not yet recruiting

Bytom 41-902, Poland; Not yet recruiting

Poznan 60-572, Poland; Not yet recruiting

Midrand, South Africa; Not yet recruiting

Pretoria 0083, South Africa; Not yet recruiting

000775 Durbanville, South Africa; Not yet recruiting

007925 Wynberg, South Africa; Not yet recruiting

Benoni, South Africa; Not yet recruiting

Panorama 7500, South Africa; Not yet recruiting

Mobile, Alabama 36604, United States; Recruiting

Birmingham, Alabama 35233, United States; Not yet recruiting

Orange, California 92868, United States; Not yet recruiting

San Francisco, California 94118, United States; Not yet recruiting

Centennial, Colorado 80112, United States; Recruiting

Thornton, Colorado 80233, United States; Recruiting

Orlando, Florida 32801, United States; Recruiting

Gainesville, Florida 32601, United States; Recruiting

Augusta, Georgia 30912, United States; Not yet recruiting

Indianapolis, Indiana 46202, United States; Not yet recruiting

Louisville, Kentucky 40202, United States; Not yet recruiting

Worcester, Massachusetts 01655, United States; Recruiting

Flint, Michigan 48503, United States; Recruiting

Southfield, Michigan 48075, United States; Recruiting

Jackson, Mississippi 39216, United States; Not yet recruiting

Omaha, Nebraska 68105, United States; Not yet recruiting

Las Vegas, Nevada 89109, United States; Not yet recruiting

Mays Landing, New Jersey 08330, United States; Recruiting

Charlotte, North Carolina 28232, United States; Not yet recruiting

Columbus, Ohio 43205, United States; Not yet recruiting

Youngstown, Ohio 44514, United States; Recruiting

Danville, Pennsylvania 17822, United States; Not yet recruiting

Hershey, Pennsylvania 17033, United States; Not yet recruiting

Kingsport, Tennessee 37660, United States; Recruiting

San Antonio, Texas 78258, United States; Recruiting

Morgantown, West Virginia 26506, United States; Not yet recruiting

To learn how to participate in this trial please click here.

Starting date: January 2009
Ending date: February 2011
Last updated: June 11, 2009