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 investigate the efficacy (ie, healing and symptom relief) and safety of Rabeprazole Extended-Release (RAB ER) 50 mg versus Esomeprazole (ESO) 40 mg for the treatment of moderate to severe erosive Gastroesophageal Reflux Disease (eGERD).

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 Extended-Release (RAB ER) 50 mg or Esomeprazole (ESO) 40 mg for the treatment of moderate to severe erosive Gastroesophageal Reflux Disease (eGERD).

Study Type

Interventional

Enrollment (Actual)

1069

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
      • La Plata, Argentina, 1900
    • BUE
      • Buenos Aires, BUE, Argentina, B1832BQS
      • Buenos Aires, BUE, Argentina, C1117ABK
    • CBA
      • Ciudad Autonoma de Bs. As., CBA, Argentina, 1431
      • Ciudad Autonoma de Bs. As., CBA, Argentina, C1120AAT
      • Ciudad Autonoma de Bs. As., CBA, Argentina, C1181ACH
    • SFE
      • Rosario, SFE, Argentina, 2000
    • TUC
      • San Miguel de Tucuman, TUC, Argentina, 4000
  • Australia
    • New South Wales
      • Penrith, New South Wales, Australia, 2751
    • Queensland
      • Caboolture, Queensland, Australia, 4510
    • South Australia
      • Adelaide, South Australia, Australia, 5001
      • Woodville, South Australia, Australia, 5011
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
    • Victoria
      • Ballarat, Victoria, Australia, 3353
      • Fitzroy, Victoria, Australia, 3065
  • Bulgaria
      • Haskovo, Bulgaria, 6300
      • Plovdiv, Bulgaria, 4000
      • Rousse, Bulgaria, 7002
      • Sofia, Bulgaria, 1606
      • Sofia, Bulgaria, 1527
  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
      • Chatham, Ontario, Canada, N7L 1B9
      • Hamilton, Ontario, Canada, L8V 1C3
      • Richmond Hill, Ontario, Canada, L4B 3P8
      • Sarnia, Ontario, Canada, N7T 4X3
      • Toronto, Ontario, Canada, M9W 4L6
      • Toronto, Ontario, Canada, M3J 1N2
      • Toronto, Ontario, Canada, M4P 1P2
      • Toronto, Ontario, Canada, M3N 2V7
    • Quebec
      • Sherbrooke, Quebec, Canada, J1G 2E8
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 1N4
  • Chile
      • Providencia, Chile
      • Santiago, Chile
      • Temuco, Chile
  • Croatia
      • Osijek, Croatia, 31 000
      • Split, Croatia, 21 000
      • Zagreb, Croatia, 10 000
  • Estonia
      • Tallinn, Estonia, 10617
      • Tallinn, Estonia, 10138
  • France
      • Saint-Quentin 2, France, 2100
    • Lyonnais
      • Lyon Cedex 3, Lyonnais, France, 69437
    • Provence
      • Marseille, Provence, France, 13015
  • Germany
    • BR
      • Potsdam, BR, Germany, 14482
    • BY
      • Freising, BY, Germany, 85356
    • NW
      • Herne, NW, Germany, 44623
      • Muenster, NW, Germany, 48167
    • RP
      • Ludwigshafen, RP, Germany, 67067
      • Mainz, RP, Germany, 55131
    • SN
      • Dresden, SN, Germany, 1307
    • ST
      • Wolmirstedt, ST, Germany, 39326
  • Hungary
      • Balatonfured, Hungary, 8230
      • Budapest, Hungary, 1088
      • Budapest, Hungary, 1201
      • Debrecen, Hungary, 4032
      • Eger, Hungary, 3300
      • Gyor, Hungary, 9024
      • Gyula, Hungary, 5700
      • Kaposvar, Hungary, 7400
      • Pecs, Hungary, 7624
      • Siofok, Hungary, 8601
      • Szekszard, Hungary, 7100
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 082
      • Hyderabad, Andhra Pradesh, India, 500001
      • Hyderabad, Andhra Pradesh, India, 500004
      • Hyderabad, Andhra Pradesh, India, 500012
      • Hyderabad, Andhra Pradesh, India, 500063
      • Hyderabad, Andhra Pradesh, India, 500082
      • Secunderabad, Andhra Pradesh, India, 500003
      • Vishakapatnam, Andhra Pradesh, India, 53002
    • Delhi
      • New Delhi, Delhi, India, 110029
    • Karnataka
      • Bangalore, Karnataka, India, 560054
      • Mangalore, Karnataka, India, 575001
    • Kerala
      • Cochin, Kerala, India, 682304
    • Punjab
      • Ludhiana, Punjab, India, 141001
    • Tamilnadu
      • Chennai, Tamilnadu, India, 600096
      • Madurai, Tamilnadu, India, 625002
  • Latvia
      • Balvi, Latvia, LV-4501
      • Daugavpils, Latvia, LV-5417
      • Riga, Latvia, LV-1006
  • Lithuania
      • Siauliai, Lithuania, LT-76231
      • Vilnius, Lithuania, LT-08661
      • Vilnius, Lithuania, 3215
  • United States
    • Illinois
      • Moline, Illinois, United States, 61265

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 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.
  3. Current esophageal strictures or esophagitis (known or suspected to be due to etiology other than GERD such as infection or medications).
  4. Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer.
  5. Current or a history of cancer, with the exception of fully excised skin basal cell carcinoma.
  6. Inflammatory bowel disease.
  7. Unstable diabetes mellitus.
  8. History of esophageal, gastric and duodenal surgery except simple suturing of an ulcer.
  9. 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
  • Masking: DOUBLE

Arms and Interventions

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

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 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm 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 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 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm 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 heartburn 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-G000-302
  • 2007-006046-17 (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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