Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients With Rabeprazole
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: rabeprazole sodium
Intervention description: administered orally and once daily to patients randomized to receive either 10 mg or 20 mg.
Intervention MeSH terms: Rabeprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 12 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: GERD

Summary:

      The primary objective of this study is to collect safety information on rabeprazole 10 mg and
      20 mg in the treatment of gastroesophageal reflux disease (GERD) in children aged 12 to 16
      years. The secondary objectives are to assess the efficacy of rabeprazole on the improvement
      of the symptoms of GERD and to explore the relationship of symptom relief to dose received,
      based on symptom frequency and severity, antacid use, and quality of life (QOL) measures.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females aged 12 to 16 years with a clinical diagnosis of symptomatic GERD or
             suspected or endoscopically proven GERD.

          2. Patients who have ever been treated with, or are currently receiving proton pump
             inhibitors (PPIs),histamine receptor (H2) blockers, or antacids are eligible (as long
             as they can go off PPIs and H2 blockers for three days prior to dosing, except for
             cimetidine, which must be discontinued for at least seven days prior to dosing;
             exclusion criteria 5 and 6). Also, patients should be able to go off PPI therapy for
             two weeks at the end active drug treatment.

          3. Children with stable asthma/reactive airways disease on stable treatment regimens are
             eligible.

          4. Children on stable doses of allergy, antiepileptic, antidepressant, and attention
             deficit disorder medicines are eligible.

          5. Patients must be able and willing to swallow the test drug tablet intact. The ability
             of the child to swallow an intact tablet must be confirmed by the site at Screening.

          6. The patient is willing and able to give assent to participate.

          7. The patient's parent or guardian gives written informed consent.

          8. Post-pubertal females will be required to be abstinent during the course of the study.

          9. Clinically insignificant laboratory findings.

        Exclusion Criteria:

          1. Evidence of significant hepatic, renal, respiratory, endocrine, immune, infectious,
             hematologic, neurologic, psychiatric, or cardiovascular system abnormalities that
             would interfere with the conduct of the study, the interpretation of study results, or
             the health of the patient during the study.

          2. History of primary esophageal motility disorders or systemic condition affecting the
             esophagus (eg, scleroderma, esophageal infections).

          3. History of eosinophilic esophagitis, persistent milk protein allergy, or allergic
             gastroenteropathy. History or current presence of peptic ulcers; current presence of
             Helicobacter pylori.

          4. History of definitive acid-lowering surgery, previous esophageal surgery, or
             esophageal stricture is disallowed. History of fundoplication or feeding tube
             insertion is allowed.

          5. Treatment with full therapeutic doses of H2-receptor antagonists or sucralfate within
             three days prior to dosing (or a shorter washout if agreed to by Investigator and
             Sponsor), except for cimetidine, which must be discontinued for at least seven days
             prior to dosing.

          6. Treatment with a proton pump inhibitor within three days prior to dosing (or a shorter
             washout if agreed to by Investigator and Sponsor).

          7. Inability to have 2-week PPI therapy-free period at end of active drug treatment.

          8. Pregnancy or lactation.

          9. Known or suspected drug addiction or alcohol abuse and/or a positive urine drug screen
             not explained by medication list; occasional alcohol or tobacco use is not an
             exclusion criterion.

         10. Unwilling or unable to abide by the requirements of the study or violating the
             prohibitions and restrictions of the study defined in Section 9.4.

         11. Any condition which would make the patient, in the opinion of the Investigator or
             Sponsor, unsuitable for the study.

         12. Participation in another investigational drug study within one month prior to dosing.

         13. A history of allergy/sensitivity to proton pump inhibitors or to their inactive
             ingredients.