Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)
NCT ID: NCT00658632
Last Updated: 2016-05-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1397 participants
INTERVENTIONAL
2008-02-29
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Rabeprazole sodium
Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks.
2
Esomeprazole
Esomeprazole 40 mg capsule, once daily for 4-8 weeks.
Interventions
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Rabeprazole sodium
Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks.
Esomeprazole
Esomeprazole 40 mg capsule, once daily for 4-8 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. History of gastroesophageal reflux disease (GERD) symptoms for at least 3 months immediately before screening.
3. Heartburn for at least 2 days a week for at least 1 month before screening.
4. Esophageal erosions of Los Angeles (LA) Grades A or B based on EGD taken within 14 days prior to enrollment.
5. Subjects who are H. pylori negative based on a screening test.
6. Females should be either of non-childbearing potential or of childbearing potential. Females of childbearing potential must have negative pregnancy tests prior to randomization. Female subjects of childbearing potential must agree to use medically acceptable methods of contraception.
7. Subjects must be able to read, write, and understand the language of the symptom diary.
Exclusion Criteria
2. 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).
3. Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer.
4. Current or a history of cancer, with the exception of fully excised skin basal cell carcinoma.
5. Inflammatory bowel disease.
6. Unstable diabetes mellitus.
7. History of esophageal, gastric and duodenal surgery except simple suturing of an ulcer.
8. Subjects who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (\>=20 mg/day prednisone or equivalent), or aspirin (\> 325 mg/day).
18 Years
75 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Yufang Lu
Role: STUDY_DIRECTOR
Eisai Inc.
Locations
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Huntsville, Alabama, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Sherwood, Arkansas, United States
Anaheim, California, United States
Chula Vista, California, United States
Fullerton, California, United States
Irvine, California, United States
Laguna Hills, California, United States
Mission Hills, California, United States
Redwood City, California, United States
San Diego, California, United States
San Louis Obispo, California, United States
West Covina, California, United States
Pueblo, Colorado, United States
Wheat Ridge, Colorado, United States
Bristol, Connecticut, United States
Hartford, Connecticut, United States
Boynton Beach, Florida, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Largo, Florida, United States
Lauderdale Lakes, Florida, United States
Naples, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Newnan, Georgia, United States
Rockford, Illinois, United States
Clive, Iowa, United States
Kansas City, Kansas, United States
Topeka, Kansas, United States
Louisville, Kentucky, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Slidell, Louisiana, United States
Annapolis, Maryland, United States
Hagerstown, Maryland, United States
Mexico, Missouri, United States
Washington, Missouri, United States
Vineland, New Jersey, United States
Albuquerque, New Mexico, United States
Bay Shore, New York, United States
Hartsdale, New York, United States
Mineola, New York, United States
New York, New York, United States
Pittsford, New York, United States
Boone, North Carolina, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Jacksonville, North Carolina, United States
New Bern, North Carolina, United States
Wilmington, North Carolina, United States
Fargo, North Dakota, United States
Dayton, Ohio, United States
Portland, Oregon, United States
Portland, Oregon, United States
Portland, Oregon, United States
Anderson, South Carolina, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Franklin, Tennessee, United States
Germantown, Tennessee, United States
Jackson, Tennessee, United States
Johnson City, Tennessee, United States
Kingsport, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Beaumont, Texas, United States
Bryan, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Chesapeake, Virginia, United States
Bellevue, Washington, United States
Spokane, Washington, United States
Spokane, Washington, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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E3810-G000-303
Identifier Type: -
Identifier Source: org_study_id
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