Comparing the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)

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.