Rabeprazole Extended-Release, 50 mg, Versus Esomeprazole, 40 mg, for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
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)
2 other identifiers
interventional
1,069
14 countries
83
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2008
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 9, 2008
CompletedFirst Posted
Study publicly available on registry
April 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
June 23, 2015
CompletedDecember 21, 2015
November 1, 2015
1.6 years
April 9, 2008
June 8, 2015
November 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks
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
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 Outcomes (1)
Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4
Week 4
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks.
Eligibility Criteria
You may qualify if:
- Male or female, ages 18 to 75 years.
- History of GERD symptoms for at least 3 months immediately before screening.
- Heartburn for at least 2 days a week for at least 1 month before screening.
- Esophageal erosions of LA Grades C or D based on EGD taken within 14 days prior to enrollment.
- Subjects who are H. pylori negative based on a screening test.
- 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.
- Subjects must be able to read, write, and understand the language of the symptom diary.
You may not qualify if:
- Current or a history of esophageal motility disorders.
- 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).
- Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer.
- Current or a history of cancer, with the exception of fully excised skin basal cell carcinoma.
- Inflammatory bowel disease.
- Unstable diabetes mellitus.
- History of esophageal, gastric and duodenal surgery except simple suturing of an ulcer.
- Subjects who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (\>= 20 mg/day prednisone or equivalent), or aspirin (\> 325 mg/day).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (83)
Unknown Facility
Moline, Illinois, 61265, United States
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La Plata, Argentina, 1900, Argentina
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Buenos Aires, BUE, B1832BQS, Argentina
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Buenos Aires, BUE, C1117ABK, Argentina
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Ciudad Autonoma de Bs. As., CBA, 1431, Argentina
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Ciudad Autonoma de Bs. As., CBA, C1120AAT, Argentina
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Ciudad Autonoma de Bs. As., CBA, C1181ACH, Argentina
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Rosario, SFE, 2000, Argentina
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San Miguel de Tucumán, TUC, 4000, Argentina
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Penrith, New South Wales, 2751, Australia
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Caboolture, Queensland, 4510, Australia
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Adelaide, South Australia, 5001, Australia
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Woodville, South Australia, 5011, Australia
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Launceston, Tasmania, 7250, Australia
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Ballarat, Victoria, 3353, Australia
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Fitzroy, Victoria, 3065, Australia
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Haskovo, Bulgaria, 6300, Bulgaria
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Plovdiv, Bulgaria, 4000, Bulgaria
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Rousse, Bulgaria, 7002, Bulgaria
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Sofia, Bulgaria, 1527, Bulgaria
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Sofia, Bulgaria, 1606, Bulgaria
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Barrie, Ontario, L4M 7G1, Canada
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Chatham, Ontario, N7L 1B9, Canada
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Hamilton, Ontario, L8V 1C3, Canada
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Richmond Hill, Ontario, L4B 3P8, Canada
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Sarnia, Ontario, N7T 4X3, Canada
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Toronto, Ontario, M3J 1N2, Canada
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Toronto, Ontario, M3N 2V7, Canada
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Toronto, Ontario, M4P 1P2, Canada
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Toronto, Ontario, M9W 4L6, Canada
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Sherbrooke, Quebec, J1G 2E8, Canada
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Saskatoon, Saskatchewan, S7K 1N4, Canada
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Providencia, Chile, Chile
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Santiago, Chile, Chile
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Temuco, Chile, Chile
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Osijek, Croatia, 31 000, Croatia
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Split, Croatia, 21 000, Croatia
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Zagreb, Croatia, 10 000, Croatia
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Tallinn, Estonia, 10138, Estonia
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Tallinn, Estonia, 10617, Estonia
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Saint-Quentin, France, 2100, France
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Lyon, Lyonnais, 69437, France
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Marseille, Provence-Alpes-Côte d'Azur Region, 13015, France
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Freising, Bavaria, 85356, Germany
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Potsdam, BR, 14482, Germany
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Herne, North Rhine-Westphalia, 44623, Germany
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Münster, North Rhine-Westphalia, 48167, Germany
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Ludwigshafen am Rhein, Rhineland-Palatinate, 67067, Germany
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Mainz, Rhineland-Palatinate, 55131, Germany
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Dresden, Saxony, 1307, Germany
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Wolmirstedt, Saxony-Anhalt, 39326, Germany
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Balatonfüred, Hungary, 8230, Hungary
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Budapest, Hungary, 1088, Hungary
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Budapest, Hungary, 1201, Hungary
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Debrecen, Hungary, 4032, Hungary
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Eger, Hungary, 3300, Hungary
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Győr, Hungary, 9024, Hungary
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Gyula, Hungary, 5700, Hungary
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Kaposvár, Hungary, 7400, Hungary
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Pécs, Hungary, 7624, Hungary
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Siófok, Hungary, 8601, Hungary
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Szekszárd, Hungary, 7100, Hungary
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Hyderabad, Andhra Pradesh, 500 082, India
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Hyderabad, Andhra Pradesh, 500001, India
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Hyderabad, Andhra Pradesh, 500004, India
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Hyderabad, Andhra Pradesh, 500012, India
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Hyderabad, Andhra Pradesh, 500063, India
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Hyderabad, Andhra Pradesh, 500082, India
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Secunderabad, Andhra Pradesh, 500003, India
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Visakhapatnam, Andhra Pradesh, 53002, India
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Bangalore, Karnataka, 560054, India
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Mangalore, Karnataka, 575001, India
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Kochi, Kerala, 682304, India
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New Delhi, National Capital Territory of Delhi, 110029, India
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Ludhiana, Punjab, 141001, India
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Chennai, Tamil Nadu, 600096, India
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Madurai, Tamil Nadu, 625002, India
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Balvi, Latvia, LV-4501, Latvia
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Daugavpils, Latvia, LV-5417, Latvia
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Riga, Latvia, LV-1006, Latvia
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Šiauliai, Lithuania, LT-76231, Lithuania
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Vilnius, Lithuania, 3215, Lithuania
Unknown Facility
Vilnius, Lithuania, LT-08661, Lithuania
Related Publications (1)
Laine L, Katz PO, Johnson DA, Ibegbu I, Goldstein MJ, Chou C, Rossiter G, Lu Y. Randomised clinical trial: a novel rabeprazole extended release 50 mg formulation vs. esomeprazole 40 mg in healing of moderate-to-severe erosive oesophagitis - the results of two double-blind studies. Aliment Pharmacol Ther. 2011 Jan;33(2):203-12. doi: 10.1111/j.1365-2036.2010.04516.x. Epub 2010 Nov 30.
PMID: 21114792DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eisai Inc.
- Organization
- Eisai Call Center
Study Officials
- STUDY DIRECTOR
Yufang Lu
Eisai Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2008
First Posted
April 15, 2008
Study Start
February 1, 2008
Primary Completion
September 1, 2009
Study Completion
January 1, 2010
Last Updated
December 21, 2015
Results First Posted
June 23, 2015
Record last verified: 2015-11