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

NCT ID: NCT00911534

Last Updated: 2016-02-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

305 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Symptomatic Gastroesophageal Reflux Disease (sGERD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

rabeprazole sodium

Intervention Type DRUG

One rabeprazole extended release (ER) 50 mg capsule daily; rescue medication will be provided to subjects to take as needed.

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One rabeprazole placebo capsule daily; rescue medication will be provided to subjects to take as needed.

Interventions

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rabeprazole sodium

One rabeprazole extended release (ER) 50 mg capsule daily; rescue medication will be provided to subjects to take as needed.

Intervention Type DRUG

Placebo

One rabeprazole placebo capsule daily; rescue medication will be provided to subjects to take as needed.

Intervention Type DRUG

Other Intervention Names

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rabeprazole sodium extended release

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillermo Rossiter, MD

Role: STUDY_DIRECTOR

Eisai Inc.

Locations

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Athens, Alabama, United States

Site Status

Huntsville, Alabama, United States

Site Status

Tucson, Arizona, United States

Site Status

Little Rock, Arkansas, United States

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Anaheim, California, United States

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Encinitas, California, United States

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Irvine, California, United States

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Lancaster, California, United States

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Los Angeles, California, United States

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Merced, California, United States

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Oceanside, California, United States

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Orange, California, United States

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Pasadena, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Wheat Ridge, Colorado, United States

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Bridgeport, Connecticut, United States

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Altamonte Springs, Florida, United States

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Boynton Beach, Florida, United States

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Cape Coral, Florida, United States

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Hialeah, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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New Smyrna Beach, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Wellington, Florida, United States

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Zephyrhills, Florida, United States

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Decatur, Georgia, United States

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Newnam, Georgia, United States

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Chicago, Illinois, United States

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Evansville, Indiana, United States

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Wichita, Kansas, United States

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Wichita, Kansas, United States

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Lake Charles, Louisiana, United States

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Metairie, Louisiana, United States

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Shreveport, Louisiana, United States

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Hagerstown, Maryland, United States

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Hollywood, Maryland, United States

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Chesterfield, Michigan, United States

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Troy, Michigan, United States

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Chaska, Minnesota, United States

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Mexico, Missouri, United States

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Butte, Montana, United States

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Haddon Heights, New Jersey, United States

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Ocean City, New Jersey, United States

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Vineland, New Jersey, United States

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Voorhees Township, New Jersey, United States

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Great Neck, New York, United States

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Great Neck, New York, United States

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Lake Success, New York, United States

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Pittsford, New York, United States

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Rochester, New York, United States

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Asheville, North Carolina, United States

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Boone, North Carolina, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Fayetteville, North Carolina, United States

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Greesnboro, North Carolina, United States

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High Point, North Carolina, United States

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Jacksonville, North Carolina, United States

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Kinston, North Carolina, United States

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New Bern, North Carolina, United States

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Raleigh, North Carolina, United States

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Rutherford College, North Carolina, United States

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Cincinnati, Ohio, United States

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Gallipolis, Ohio, United States

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Mentor, Ohio, United States

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Perrysburg, Ohio, United States

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Norman, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Charleston, South Carolina, United States

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Simpsonville, South Carolina, United States

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Franklin, Tennessee, United States

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Jackson, Tennessee, United States

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Johnson City, Tennessee, United States

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Joshson City, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Corsicana, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Laredo, Texas, United States

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Odessa, Texas, United States

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Overland Park, Texas, United States

Site Status

San Antonio, Texas, United States

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Sugar Land, Texas, United States

Site Status

Bountiful, Utah, United States

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Ogden, Utah, United States

Site Status

West Valley City, Utah, United States

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Charlottesville, Virginia, United States

Site Status

Christiansburg, Virginia, United States

Site Status

Madison, Wisconsin, United States

Site Status

Milwaukee, Wisconsin, United States

Site Status

Monroe, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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E3810-A001-307

Identifier Type: -

Identifier Source: org_study_id

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