Maintenance Intermittent Therapy for Symptomatic GERD Patients
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Intervention: Rabeprazole 20 mg
Intervention description: rabeprazole sodium tablet 20 mg once daily
Intervention MeSH terms: Rabeprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: non-erosive symptomatic GERD; GERD

Summary:

      The purpose of this study to determine the efficacy of 20 mg of rabeprazole given as a
      maintenance intermittent therapy following acute treatment for Symptomatic Gastroesophageal
      Reflux Disease (s-GERD).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female patients, 18 to 65 years of age.

          2. If female, not of childbearing potential by reason of surgery, radiation or menopause,
             or of childbearing potential, but using an approved method of contraception since the
             last menstrual period, for example, intrauterine device (IUD), implant, double barrier
             method, or oral contraceptives for at least one cycle. Females of childbearing
             potential must have a negative urine pregnancy test before medication is dispensed.

          3. Patients must report a minimum three-month history of GERD symptoms. GERD symptoms are
             defined as heartburn with or without regurgitation or other associated GERD symptoms.

          4. Patients must have at least 4 days with heartburn per week in each of the 2 weeks
             prior to Screening.

          5. Patients must have no esophagitis, with no proton pump inhibitors (PPIs, prescription
             or OTC), H2 blockers (prescription or OTC) or prokinetics within 14 days, prior to the
             endoscopy.

        Key Exclusion Criteria:

          1. Evidence of significant hepatic, renal, respiratory, endocrine, hematologic,
             neurologic, psychiatric or cardiovascular system abnormalities, unless the Sponsor and
             Investigator agree that the nature and severity of any abnormality is unlikely to
             interfere with the conduct of the study, the interpretation of study results, or the
             health of the patient during the study.

          2. Females must not be pregnant, lactating or have a positive urine eta human chorionic
             gonadotropin (B-hCG) laboratory result.

          3. Patients with a history of allergy or sensitivity to proton pump inhibitors or to
             their inactive ingredients.

          4. Patients with known gastric ulcer, duodenal ulcer, infectious or inflammatory
             conditions of the small or large intestine, malabsorption syndromes, obstruction, a
             history of gastrointestinal malignancy, or prior gastric or intestinal surgery
             (including vagotomy).

          5. Patients who have a history of Barrett's esophagus, esophageal stricture, or pyloric
             stenosis.

          6. Patients with a history of endoscopically-proven esophagitis any time in the past.

          7. Patients who have taken proton pump inhibitors (PPIs, prescription or OTC), H2
             blockers (prescription or OTC) or prokinetics within 14 days, prior to Screening
             endoscopy, or any of these medications within 7 days prior to the single-blind placebo
             run-in period.