Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)
Launched by EISAI INC. · Apr 14, 2008
Trial Information
Current as of May 29, 2025
Completed
Keywords
ClinConnect Summary
This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, Rabeprazole Extended-Release (RAB ER) 50 mg or Esomeprazole (ESO) 40 mg for the treatment of mild to moderate erosive Gastroesophageal Reflux Disease (GERD).
Gender
ALL
Eligibility criteria
- KEY INCLUSION CRITERIA:
- • 1. Male or female, ages 18 to 75 years.
- • 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.
- KEY EXCLUSION CRITERIA:
- • 1. Current or a history of esophageal motility disorders.
- • 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).
About Eisai Inc.
Eisai Inc. is a global pharmaceutical company committed to providing innovative solutions for patients with unmet medical needs. With a strong focus on neurology and oncology, Eisai leverages cutting-edge research and development to advance therapeutics that enhance patient outcomes and quality of life. The company emphasizes a patient-centric approach, fostering collaboration with healthcare professionals and stakeholders to ensure the effective delivery of its products. Eisai Inc. is dedicated to upholding the highest ethical standards in clinical trials, driving scientific excellence, and contributing to the advancement of healthcare worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Antonio, Texas, United States
Newnan, Georgia, United States
Portland, Oregon, United States
Bryan, Texas, United States
Tucson, Arizona, United States
Charlotte, North Carolina, United States
Portland, Oregon, United States
Nashville, Tennessee, United States
Milwaukee, Wisconsin, United States
Dallas, Texas, United States
Naples, Florida, United States
Orlando, Florida, United States
Louisville, Kentucky, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Fort Worth, Texas, United States
New York, New York, United States
Houston, Texas, United States
Dayton, Ohio, United States
Kingsport, Tennessee, United States
Washington, District Of Columbia, United States
San Diego, California, United States
Wheat Ridge, Colorado, United States
Tampa, Florida, United States
Mineola, New York, United States
Fargo, North Dakota, United States
Huntsville, Alabama, United States
Kansas City, Missouri, United States
Charlotte, North Carolina, United States
Jacksonville, Florida, United States
Fullerton, California, United States
Albuquerque, New Mexico, United States
Dallas, Texas, United States
Orlando, Florida, United States
Germantown, Tennessee, United States
Bellevue, Washington, United States
Tucson, Arizona, United States
Charleston, South Carolina, United States
Houston, Texas, United States
Annapolis, Maryland, United States
Chapel Hill, North Carolina, United States
Nashville, Tennessee, United States
Wilmington, North Carolina, United States
Dayton, Ohio, United States
Germantown, Tennessee, United States
Jackson, Mississippi, United States
Spokane, Washington, United States
Columbia, Maryland, United States
Laguna Hills, California, United States
Clive, Iowa, United States
Hagerstown, Maryland, United States
Anaheim, California, United States
Johnson City, New York, United States
Jupiter, Florida, United States
Slidell, Louisiana, United States
Chesapeake, Virginia, United States
Baton Rouge, Louisiana, United States
Bayshore, New York, United States
Hialeah, Florida, United States
Mission Hills, California, United States
Bristol, Tennessee, United States
Kingsport, Tennessee, United States
Mexico, Missouri, United States
Slidell, Louisiana, United States
Wilmington, North Carolina, United States
Topeka, Kansas, United States
Fargo, North Dakota, United States
San Antonio, Texas, United States
Chula Vista, California, United States
Little Rock, Arkansas, United States
Louisville, Kentucky, United States
New Bern, North Carolina, United States
Beaumont, Texas, United States
Rockford, Illinois, United States
New York, New York, United States
Largo, Florida, United States
Boone, North Carolina, United States
Boynton Beach, Florida, United States
San Diego, California, United States
Pueblo, Colorado, United States
Franklin, Indiana, United States
Irvine, California, United States
Jacksonville, Florida, United States
Hollywood, California, United States
Hartford, Connecticut, United States
Anderson, Indiana, United States
Milwaukee, Michigan, United States
Madison, Wisconsin, United States
Sherwood, Arkansas, United States
Redwood, California, United States
San Louis Obispo, California, United States
West Covina, California, United States
Hialeah, Florida, United States
Lauderdale Lakes, Florida, United States
Vineland, New Jersey, United States
Hartsdale, New York, United States
Pittsford, New York, United States
Patients applied
Trial Officials
Yufang Lu
Study Director
Eisai Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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