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

Last updated: November 19, 2015
Sponsor: Eisai Inc.
Overall Status: Completed

Phase

3

Condition

Gastroparesis

Heartburn

Heartburn (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00658528
E3810-G000-301
2007-005570-32
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease (GERD).

Eligibility Criteria

Inclusion

KEY INCLUSION CRITERIA:

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

  2. History of 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 C or D 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: 1061
Study Start date:
February 01, 2008
Estimated Completion Date:
January 31, 2010

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 ER 50 mg or Esomeprazole 40 mg for the treatment of moderate to severe erosive GERD.

Connect with a study center

  • Isidro Casanova, La Matanza, BUE 1765
    Argentina

    Site Not Available

  • Ramos Mejia, BUE 1221
    Argentina

    Site Not Available

  • San Isidro, BUE B1642BHH
    Argentina

    Site Not Available

  • Capital Federal, CBA C1425DND
    Argentina

    Site Not Available

  • Mendoza, MEN 5500
    Argentina

    Site Not Available

  • Rosario, SFE S2000CVB
    Argentina

    Site Not Available

  • San Juan, SJN 5447
    Argentina

    Site Not Available

  • Five Dock, New South Wales 2046
    Australia

    Site Not Available

  • Carina Heights, Queensland 4152
    Australia

    Site Not Available

  • Kippa Ring, Queensland 4021
    Australia

    Site Not Available

  • Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Frankston, Victoria 3199
    Australia

    Site Not Available

  • Malvern, Victoria 3144
    Australia

    Site Not Available

  • Plovdiv, 4000
    Bulgaria

    Site Not Available

  • Sofia, 1431
    Bulgaria

    Site Not Available

  • Stara Zagora, 6000
    Bulgaria

    Site Not Available

  • Varna, 9010
    Bulgaria

    Site Not Available

  • Saint John, New Brunswick E2K 1J5
    Canada

    Site Not Available

  • St. John's, Newfoundland and Labrador A1A 3R5
    Canada

    Site Not Available

  • Guelph, Ontario N1H 3R3
    Canada

    Site Not Available

  • Hamilton, Ontario L8N 3Z5
    Canada

    Site Not Available

  • Newmarket, Ontario L3Y 5G8
    Canada

    Site Not Available

  • Toronto, Ontario M6H 3M1
    Canada

    Site Not Available

  • Windsor, Ontario N8W 1E6
    Canada

    Site Not Available

  • Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Pointe-Claire, Quebec H9R 3J1
    Canada

    Site Not Available

  • Saskatoon, Saskatchewan S7K 1J5
    Canada

    Site Not Available

  • Quebec, G1R 2J6
    Canada

    Site Not Available

  • Santiago,
    Chile

    Site Not Available

  • Vioa del Mar,
    Chile

    Site Not Available

  • Rijeka, 51 000
    Croatia

    Site Not Available

  • Zagreb, 10 000
    Croatia

    Site Not Available

  • Tartu, 51014
    Estonia

    Site Not Available

  • empty

    Marseille, 13 13009
    France

    Site Not Available

  • empty

    La Chaussee St. Victor, 41 41260
    France

    Site Not Available

  • empty

    Nice Cedex 3, 6 6100
    France

    Site Not Available

  • empty

    Lyon Cedex 3, 69 69437
    France

    Site Not Available

  • empty

    Dieppe, 76 76200
    France

    Site Not Available

  • Dieppe 76, 76200
    France

    Site Not Available

  • La Chaussee St. Victor 41, 41260
    France

    Site Not Available

  • Lyon Cedex 369, 69437
    France

    Site Not Available

  • Marseille 13, 13009
    France

    Site Not Available

  • Nice Cedex 36, 6100
    France

    Site Not Available

  • Berlin, BE 10967
    Germany

    Site Not Available

  • Mannheim, BW 68167
    Germany

    Site Not Available

  • Muenchen, BY 81669
    Germany

    Site Not Available

  • Dietzenbach, HE 63128
    Germany

    Site Not Available

  • Marburg, HE 35033
    Germany

    Site Not Available

  • Wiesbaden, HE 65185
    Germany

    Site Not Available

  • Hamburg, HH 22143
    Germany

    Site Not Available

  • Dortmund, NW 44137
    Germany

    Site Not Available

  • Lienen/Kattenve nne, NW 49536
    Germany

    Site Not Available

  • Muenster, NW 48159
    Germany

    Site Not Available

  • Budapest, 1036
    Hungary

    Site Not Available

  • Dunaujvaros, 2400
    Hungary

    Site Not Available

  • Kisber, 2870
    Hungary

    Site Not Available

  • Miskolc, 3530
    Hungary

    Site Not Available

  • Nagykanizsa, 8800
    Hungary

    Site Not Available

  • Nyiregyhaza, 4400
    Hungary

    Site Not Available

  • Szentes, 6600
    Hungary

    Site Not Available

  • Veszprem, 8200
    Hungary

    Site Not Available

  • Zalaegerszeg, 8900
    Hungary

    Site Not Available

  • New Delhi, Delhi 110002
    India

    Site Not Available

  • Ahmedabad, Gujarat 380006
    India

    Site Not Available

  • Manipal, Karnataka 576104
    India

    Site Not Available

  • Bhopal, Madhya Pradesh 462038
    India

    Site Not Available

  • Aurangabad, Maharashtra 431005
    India

    Site Not Available

  • Mumbai, Maharashtra 400016
    India

    Site Not Available

  • Nagpur, Maharashtra 440012
    India

    Site Not Available

  • Pune, Maharashtra PUNE-411013
    India

    Site Not Available

  • Thane, Maharashtra 400001
    India

    Site Not Available

  • Ludhiana, Punjab 141008
    India

    Site Not Available

  • Jaipur, Rajasthan 302001
    India

    Site Not Available

  • Lucknow, Uttar Pradesh 226003
    India

    Site Not Available

  • Riga, LV-1005
    Latvia

    Site Not Available

  • Anaheim, California 92801
    United States

    Site Not Available

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