Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)

Last updated: March 28, 2016
Sponsor: Eisai Inc.
Overall Status: Completed

Phase

3

Condition

Gastroesophageal Reflux Disease (Gerd)

Gastroparesis

Stomach Discomfort

Treatment

N/A

Clinical Study ID

NCT00658632
E3810-G000-303
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to investigate the efficacy and safety of Rabeprazole (RAB) Extended-Release (ER) 50 mg versus Esomeprazole (ESO) 40 mg in subjects with erosive gastroesophageal reflux disease (eGERD).

Eligibility Criteria

Inclusion

KEY INCLUSION CRITERIA:

  1. Male or female, ages 18 to 75 years.

  2. History of gastroesophageal reflux disease (GERD) symptoms for at least 3 monthsimmediately 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 14days 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 torandomization. Female subjects of childbearing potential must agree to use medicallyacceptable methods of contraception.

  7. Subjects must be able to read, write, and understand the language of the symptomdiary.

Exclusion

KEY EXCLUSION CRITERIA:

  1. Current or a history of esophageal motility disorders.

  2. Current or a history of Barrett's esophagus. Current esophageal strictures oresophagitis (known or suspected to be due to etiology other than GERD such asinfection or medications).

  3. Current or a history of Zollinger-Ellison syndrome and other acid hypersecretoryconditions, or current gastric or duodenal ulcer.

  4. Current or a history of cancer, with the exception of fully excised skin basal cellcarcinoma.

  5. Inflammatory bowel disease.

  6. Unstable diabetes mellitus.

  7. History of esophageal, gastric and duodenal surgery except simple suturing of anulcer.

  8. Subjects who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oralsteroids (>=20 mg/day prednisone or equivalent), or aspirin (> 325 mg/day).

Study Design

Total Participants: 1397
Study Start date:
February 01, 2008
Estimated Completion Date:
September 30, 2009

Study Description

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).

Connect with a study center

  • Huntsville, Alabama 35801
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  • Tucson, Arizona 85741
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  • Little Rock, Arkansas 72205
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  • Sherwood, Arkansas 72120
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  • Anaheim, California 92801
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  • Chula Vista, California 91910
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  • Fullerton, California 92835
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  • Irvine, California 92618
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  • Laguna Hills, California 92653
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  • Mission Hills, California 91345
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  • Redwood, California 94062
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  • San Diego, California 92123
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  • San Louis Obispo, California 93405
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  • West Covina, California 91790
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  • Pueblo, Colorado 81008
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  • Wheat Ridge, Colorado 80033
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  • Bristol, Connecticut 6010
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  • Hartford, Connecticut 6102
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  • Boynton Beach, Florida 33426
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  • Hialeah, Florida 33010
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  • Hollywood, Florida 33021
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  • Jacksonville, Florida 32256
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  • Jupiter, Florida 33458
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  • Largo, Florida 33777
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  • Lauderdale Lakes, Florida 33319
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  • Naples, Florida 34102
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  • Orlando, Florida 32806
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  • Tampa, Florida 33618
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  • Newnan, Georgia 30263
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  • Rockford, Illinois 61107
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  • Clive, Iowa 50325
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  • Kansas City, Kansas 66160
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  • Topeka, Kansas 66606
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  • Louisville, Kentucky 40291
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  • Baton Rouge, Louisiana 70809
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  • Slidell, Louisiana 70458
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  • Annapolis, Maryland 21401
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  • Hagerstown, Maryland 21742
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  • Mexico, Missouri 65265
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  • Washington, Missouri 63090
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  • Vineland, New Jersey 8360
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  • Albuquerque, New Mexico 87106
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  • Bayshore, New York 11706
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  • Hartsdale, New York 10530
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  • Mineola, New York 11501
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  • New York, New York 10021
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  • Pittsford, New York 14534
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  • Boone, North Carolina 28607
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  • Chapel Hill, North Carolina 27599
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  • Charlotte, North Carolina 28209
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  • New Bern, North Carolina 28562
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  • Wilmington, North Carolina 28401
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  • Fargo, North Dakota 58104
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  • Dayton, Ohio 45415
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  • Portland, Oregon 97220
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  • Anderson, South Carolina 29621
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  • Charleston, South Carolina 29414
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  • Columbia, South Carolina 29203
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  • Franklin, Tennessee 37067
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  • Germantown, Tennessee 38138
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  • Jackson, Tennessee 38301
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  • Johnson City, Tennessee 37604
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  • Kingsport, Tennessee 37660
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  • Nashville, Tennessee 37203
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  • Beaumont, Texas 77701
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  • Bryan, Texas 77802
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  • Dallas, Texas 75231
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  • Fort Worth, Texas 76104
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  • Houston, Texas 77079
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  • San Antonio, Texas 78229
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  • Chesapeake, Virginia 23320
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  • Bellevue, Washington 98004
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  • Spokane, Washington 99216
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  • Madison, Wisconsin 53715
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  • Milwaukee, Wisconsin 53215
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