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
1,061
13 countries
88
Brief 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).
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
88 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 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
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 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, taken orally, 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 Los Angeles (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 (88)
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
Isidro Casanova, La Matanza, BUE, 1765, Argentina
Unknown Facility
Ramos Mejía, BUE, 1221, Argentina
Unknown Facility
San Isidro, BUE, B1642BHH, Argentina
Unknown Facility
Capital Federal, CBA, C1425DND, Argentina
Unknown Facility
Mendoza, MEN, 5500, Argentina
Unknown Facility
Rosario, SFE, S2000BLG, Argentina
Unknown Facility
Rosario, SFE, S2000CRF, Argentina
Unknown Facility
Rosario, SFE, S2000CVB, Argentina
Unknown Facility
San Juan, SJN, 5447, Argentina
Unknown Facility
Five Dock, New South Wales, 2046, Australia
Unknown Facility
Carina Heights, Queensland, 4152, Australia
Unknown Facility
Kippa-Ring, Queensland, 4021, Australia
Unknown Facility
Box Hill, Victoria, 3128, Australia
Unknown Facility
Frankston, Victoria, 3199, Australia
Unknown Facility
Malvern, Victoria, 3144, Australia
Unknown Facility
Plovdiv, Bulgaria, 4000, Bulgaria
Unknown Facility
Sofia, Bulgaria, 1233, Bulgaria
Unknown Facility
Sofia, Bulgaria, 1407, Bulgaria
Unknown Facility
Sofia, Bulgaria, 1431, Bulgaria
Unknown Facility
Sofia, Bulgaria, 1709, Bulgaria
Unknown Facility
Stara Zagora, Bulgaria, 6000, Bulgaria
Unknown Facility
Varna, Bulgaria, 9010, Bulgaria
Unknown Facility
Saint John, New Brunswick, E2K 1J5, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, A1A 3R5, Canada
Unknown Facility
Guelph, Ontario, N1H 3R3, Canada
Unknown Facility
Hamilton, Ontario, L8N 3Z5, Canada
Unknown Facility
Newmarket, Ontario, L3Y 5G8, Canada
Unknown Facility
Toronto, Ontario, M6H 3M1, Canada
Unknown Facility
Windsor, Ontario, N8W 1E6, Canada
Unknown Facility
Montreal, Quebec, H1T 2M4, Canada
Unknown Facility
Montreal, Quebec, H3A 1A1, Canada
Unknown Facility
Pointe-Claire, Quebec, H9R 3J1, Canada
Unknown Facility
Québec, Quebec, G1L 3L5, Canada
Unknown Facility
Québec, Quebec, G1R 2J6, Canada
Unknown Facility
Saskatoon, Saskatchewan, S7K 1J5, Canada
Unknown Facility
Santiago, Chile, Chile
Unknown Facility
Vioa Del Mar, Chile, Chile
Unknown Facility
Rijeka, Croatia, 51 000, Croatia
Unknown Facility
Zagreb, Croatia, 10 000, Croatia
Unknown Facility
Tartu, Estonia, 51014, Estonia
Unknown Facility
Dieppe, France, 76200, France
Unknown Facility
La Chaussée-Saint-Victor, France, 41260, France
Unknown Facility
Lyon, France, 69437, France
Unknown Facility
Marseille 13, France, 13009, France
Unknown Facility
Nice, France, 6100, France
Unknown Facility
Mannheim, Baden-Wurttemberg, 68167, Germany
Unknown Facility
Munich, Bavaria, 81669, Germany
Unknown Facility
Hamburg, Hamburg, 22143, Germany
Unknown Facility
Dietzenbach, Hesse, 63128, Germany
Unknown Facility
Marburg, Hesse, 35033, Germany
Unknown Facility
Wiesbaden, Hesse, 65185, Germany
Unknown Facility
Dortmund, North Rhine-Westphalia, 44137, Germany
Unknown Facility
Lienen/Kattenve Nne, North Rhine-Westphalia, 49536, Germany
Unknown Facility
Münster, North Rhine-Westphalia, 48159, Germany
Unknown Facility
Berlin, State of Berlin, 10967, Germany
Unknown Facility
Berlin, State of Berlin, 13509, Germany
Unknown Facility
Budapest, Hungary, 1036, Hungary
Unknown Facility
Dunaújváros, Hungary, 2400, Hungary
Unknown Facility
Kisbér, Hungary, 2870, Hungary
Unknown Facility
Miskolc, Hungary, 3530, Hungary
Unknown Facility
Nagykanizsa, Hungary, 8800, Hungary
Unknown Facility
Nyíregyháza, Hungary, 4400, Hungary
Unknown Facility
Szentes, Hungary, 6600, Hungary
Unknown Facility
Veszprém, Hungary, 8200, Hungary
Unknown Facility
Zalaegerszeg, Hungary, 8900, Hungary
Unknown Facility
Ahmedabad, Gujarat, 380006, India
Unknown Facility
Manipal, Karnataka, 576104, India
Unknown Facility
Bhopal, Madhya Pradesh, 462038, India
Unknown Facility
Aurangabad, Maharashtra, 431005, India
Unknown Facility
Mumbai, Maharashtra, 400 022, India
Unknown Facility
Mumbai, Maharashtra, 400012, India
Unknown Facility
Mumbai, Maharashtra, 400016, India
Unknown Facility
Mumbai, Maharashtra, 400020, India
Unknown Facility
Nagpur, Maharashtra, 440012, India
Unknown Facility
Pune, Maharashtra, 411001, India
Unknown Facility
Pune, Maharashtra, 411004, India
Unknown Facility
Pune, Maharashtra, PUNE-411013, India
Unknown Facility
Thane, Maharashtra, 400001, India
Unknown Facility
New Delhi, National Capital Territory of Delhi, 110 060, India
Unknown Facility
New Delhi, National Capital Territory of Delhi, 110002, India
Unknown Facility
New Delhi, National Capital Territory of Delhi, 110017, India
Unknown Facility
Ludhiana, Punjab, 141008, India
Unknown Facility
Jaipur, Rajasthan, 302001, India
Unknown Facility
Jaipur, Rajasthan, 302004, India
Unknown Facility
Lucknow, Uttar Pradesh, 226003, India
Unknown Facility
Riga, Latvia, LV-1002, Latvia
Unknown Facility
Riga, Latvia, LV-1005, Latvia
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, MD, PhD
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