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

November 19, 2015 updated by: Eisai Inc.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

1061

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • BUE
      • Isidro Casanova, La Matanza, BUE, Argentina, 1765
      • Ramos Mejia, BUE, Argentina, 1221
      • San Isidro, BUE, Argentina, B1642BHH
    • CBA
      • Capital Federal, CBA, Argentina, C1425DND
    • MEN
      • Mendoza, MEN, Argentina, 5500
    • SFE
      • Rosario, SFE, Argentina, S2000BLG
      • Rosario, SFE, Argentina, S2000CRF
      • Rosario, SFE, Argentina, S2000CVB
    • SJN
      • San Juan, SJN, Argentina, 5447
  • Australia
    • New South Wales
      • Five Dock, New South Wales, Australia, 2046
    • Queensland
      • Carina Heights, Queensland, Australia, 4152
      • Kippa Ring, Queensland, Australia, 4021
    • Victoria
      • Box Hill, Victoria, Australia, 3128
      • Frankston, Victoria, Australia, 3199
      • Malvern, Victoria, Australia, 3144
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
      • Sofia, Bulgaria, 1233
      • Sofia, Bulgaria, 1431
      • Sofia, Bulgaria, 1709
      • Sofia, Bulgaria, 1407
      • Stara Zagora, Bulgaria, 6000
      • Varna, Bulgaria, 9010
  • Canada
      • Quebec, Canada, G1R 2J6
      • Quebec, Canada, G1L 3L5
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2K 1J5
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 3R5
    • Ontario
      • Guelph, Ontario, Canada, N1H 3R3
      • Hamilton, Ontario, Canada, L8N 3Z5
      • Newmarket, Ontario, Canada, L3Y 5G8
      • Toronto, Ontario, Canada, M6H 3M1
      • Windsor, Ontario, Canada, N8W 1E6
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
      • Montreal, Quebec, Canada, H3A 1A1
      • Pointe-Claire, Quebec, Canada, H9R 3J1
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 1J5
  • Chile
      • Santiago, Chile
      • Vioa del Mar, Chile
  • Croatia
      • Rijeka, Croatia, 51 000
      • Zagreb, Croatia, 10 000
  • Estonia
      • Tartu, Estonia, 51014
  • France
      • Dieppe 76, France, 76200
      • La Chaussee St. Victor 41, France, 41260
      • Lyon Cedex 369, France, 69437
      • Marseille 13, France, 13009
      • Nice Cedex 36, France, 6100
  • Germany
    • BE
      • Berlin, BE, Germany, 10967
      • Berlin, BE, Germany, 13509
    • BW
      • Mannheim, BW, Germany, 68167
    • BY
      • Muenchen, BY, Germany, 81669
    • HE
      • Dietzenbach, HE, Germany, 63128
      • Marburg, HE, Germany, 35033
      • Wiesbaden, HE, Germany, 65185
    • HH
      • Hamburg, HH, Germany, 22143
    • NW
      • Dortmund, NW, Germany, 44137
      • Lienen/Kattenve nne, NW, Germany, 49536
      • Muenster, NW, Germany, 48159
  • Hungary
      • Budapest, Hungary, 1036
      • Dunaujvaros, Hungary, 2400
      • Kisber, Hungary, 2870
      • Miskolc, Hungary, 3530
      • Nagykanizsa, Hungary, 8800
      • Nyiregyhaza, Hungary, 4400
      • Szentes, Hungary, 6600
      • Veszprem, Hungary, 8200
      • Zalaegerszeg, Hungary, 8900
  • India
    • Delhi
      • New Delhi, Delhi, India, 110002
      • New Delhi, Delhi, India, 110 060
      • New Delhi, Delhi, India, 110017
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
    • Karnataka
      • Manipal, Karnataka, India, 576104
    • Madhya Pradesh
      • Bhopal, Madhya Pradesh, India, 462038
    • Maharashtra
      • Aurangabad, Maharashtra, India, 431005
      • Mumbai, Maharashtra, India, 400016
      • Mumbai, Maharashtra, India, 400012
      • Mumbai, Maharashtra, India, 400 022
      • Mumbai, Maharashtra, India, 400020
      • Nagpur, Maharashtra, India, 440012
      • Pune, Maharashtra, India, 411001
      • Pune, Maharashtra, India, 411004
      • Pune, Maharashtra, India, PUNE-411013
      • Thane, Maharashtra, India, 400001
    • Punjab
      • Ludhiana, Punjab, India, 141008
    • Rajasthan
      • Jaipur, Rajasthan, India, 302001
      • Jaipur, Rajasthan, India, 302004
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
  • Latvia
      • Riga, Latvia, LV-1002
      • Riga, Latvia, LV-1005
  • United States
    • California
      • Anaheim, California, United States, 92801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Rabeprazole sodium
Rabeprazole ER 50 mg capsule, taken orally, once daily for 4-8 weeks.
Other Names:
  • Aciphex
Active Comparator: 2
Drug: Esomeprazole
Esomeprazole 40 mg capsule, taken orally, once daily for 4-8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks
Time Frame: Baseline and Week 8

Healing at week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade C or D from Baseline. Classifications include:

Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).

Grade A: One or more mucosal breaks not more than 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of 2 mucosal folds.

Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.

Gread D: Mucosal breaks involving at least 75% of the esophageal circumference.
Baseline and Week 8
Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks
Time Frame: Baseline and Week 4

Healing at week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade C or D from Baseline. Classifications include:

Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).

Grade A: One or more mucosal breaks not more than 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of 2 mucosal folds.

Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.

Grade D: Mucosal breaks involving at least 75% of the esophageal circumference.
Baseline and Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4
Time Frame: Week 4
During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of hearburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days.
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

April 9, 2008

First Submitted That Met QC Criteria

April 14, 2008

First Posted (Estimate)

April 15, 2008

Study Record Updates

Last Update Posted (Estimate)

December 21, 2015

Last Update Submitted That Met QC Criteria

November 19, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E3810-G000-301
  • 2007-005570-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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