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A Study of the Safety and Effectiveness of Rabeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients.
This study is currently recruiting participants.
Verified by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., June 2009
First Received: November 6, 2008   Last Updated: June 11, 2009   History of Changes
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator: Eisai Inc.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00787891
  Purpose

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).


Condition Intervention Phase
GERD
Gastroesophageal Reflux Disease
Drug: rabeprazole
Phase III

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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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. [ Time Frame: Evaluate the efficacy (endoscopic/histological healing) and safety of 2 dose levels (0.5 mg/kg and 1.0 mg/kg) ofa pediatric bead formulation in a 12 week design followed by long-term safety and efficacy assessment in a 24-week maintenance. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Evaluate changes from baseline of endoscopic and histological grade, the percentage of subjects with improvement in pH>4; chanes in weekly average GERD scores & symptoms ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
001: Experimental Drug: rabeprazole
0.5mg/kg once daily for 12 weeks plus option for F/u another 24 weeks
002: Experimental Drug: rabeprazole
1.0 mg/kg once daily for 12 weeks plus option for F/u another 24 weeks

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.

  Eligibility

Ages Eligible for Study:   1 Year to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787891

Contacts
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: info1@veritasmedicine.com

  Show 73 Study Locations
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Eisai Inc.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C ( Senior Director, Clinical Research and Development )
Study ID Numbers: CR014833, RABGRD3003
Study First Received: November 6, 2008
Last Updated: June 11, 2009
ClinicalTrials.gov Identifier: NCT00787891     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Rabeprazole
GERD
Endoscopy
Ulcerative Gastroesophageal Reflux Disease
Pediatrics
Erosive Gastroesophageal Reflux Disease

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions
Esophageal Motility Disorders
Deglutition Disorders
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases
Rabeprazole

ClinicalTrials.gov processed this record on February 08, 2010