Comparing the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)
Condition: Symptomatic Gastroesophageal Reflux Disease (sGERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: rabeprazole sodium; Placebo
Intervention description: One rabeprazole extended release (ER) 50 mg capsule daily; rescue medication will be provided to subjects to take as needed.; One rabeprazole placebo capsule daily; rescue medication will be provided to subjects to take as needed.
Intervention MeSH terms: Rabeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 305.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Gastroesophageal Reflux Disease; GERD

Summary:

      The purpose of this study is to compare the efficacy, safety and tolerability of rabeprazole
      extended release (ER) 50 mg with placebo in subjects with symptomatic gastroesophageal reflux
      disease (sGERD).
    

Eligibility criteria:

        KEY INCLUSION CRITERIA:

        Male or female, ages 18 through 75 years will be included in the study. Females should be
        either of nonchildbearing potential or of childbearing potential. Females of childbearing
        potential must have negative serum and urine pregnancy tests prior to randomization. Female
        subjects of childbearing potential must agree to use medically acceptable methods of
        contraception starting at Visit 1 and throughout the entire study period and for 1 month
        after the last dose of study drug. Women using hormonal contraceptives must also be using
        an additional approved method of contraception starting at Visit 1 and throughout the
        entire study period and for 1 month after the last dose of study drug. Pregnant or
        lactating females are excluded. Subjects must have a history of heartburn, identified as
        their main complaint, for 6 months or longer.Subjects must have documentation of a minimum
        of 5 moderate to severe heartburn episodes, 3 of which occur during the daytime and 1 of
        which occurs during the nighttime, during the last 7 days before randomization. Subjects
        must be able to read, write, and understand the language of the symptom dairy.

        KEY EXCLUSION CRITERIA:

        Subjects will be excluded from the study if they are found to have erosive esophagitis
        during esophagogastroduodenoscopy (EGD) at Screening, current or a history of esophageal
        motility disorders, current or a history of Barrett's esophagus, current esophageal
        strictures or esophagitis (known or suspected to be due to etiology other than GERD such as
        infection or medications), current or a history of Zollinger-Ellison syndrome and acid
        hypersecretory conditions, or current gastric or duodenal ulcer. Subjects will be excluded
        if they are found to have current or a history of cancer, with the exception of fully
        excised skin basal cell carcinoma, inflammatory bowel disease, a history of esophageal,
        gastric and duodenal surgery, except simple closure of a perforated ulcer. Subjects will be
        excluded who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral
        steroids (>=20 mg/day prednisone or equivalent), or aspirin (>325 mg/day). Female subjects
        will be excluded who are pregnant, lactating, or have a positive B-human gonadotropin test
        at Screening/Baseline. Subjects will be excluded who are known to be human immunodeficiency
        virus (HIV) positive, have participated in another investigational drug study within 30
        days prior to screening or are expected to receive an investigational drug during this
        trial. Subjects who are unwilling to provide informed consent will be excluded.