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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Eisai Inc.
• Treatments: Rabeprazole

Criteria

Inclusion Criteria:

• History of at least 1 Gastroesophageal Reflux Disease (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