Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
NCT ID: NCT00658528
Last Updated: 2015-12-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1061 participants
INTERVENTIONAL
2008-02-29
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Rabeprazole sodium
Rabeprazole ER 50 mg capsule, taken orally, once daily for 4-8 weeks.
2
Esomeprazole
Esomeprazole 40 mg capsule, taken orally, once daily for 4-8 weeks.
Interventions
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Rabeprazole sodium
Rabeprazole ER 50 mg capsule, taken orally, once daily for 4-8 weeks.
Esomeprazole
Esomeprazole 40 mg capsule, taken orally, once daily for 4-8 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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).
18 Years
75 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Yufang Lu, MD, PhD
Role: STUDY_DIRECTOR
Eisai Inc.
Locations
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Anaheim, California, United States
Isidro Casanova, La Matanza, BUE, Argentina
Ramos Mejía, BUE, Argentina
San Isidro, BUE, Argentina
Capital Federal, CBA, Argentina
Mendoza, MEN, Argentina
Rosario, SFE, Argentina
Rosario, SFE, Argentina
Rosario, SFE, Argentina
San Juan, SJN, Argentina
Five Dock, New South Wales, Australia
Carina Heights, Queensland, Australia
Kippa-Ring, Queensland, Australia
Box Hill, Victoria, Australia
Frankston, Victoria, Australia
Malvern, Victoria, Australia
Plovdiv, Bulgaria, Bulgaria
Sofia, Bulgaria, Bulgaria
Sofia, Bulgaria, Bulgaria
Sofia, Bulgaria, Bulgaria
Sofia, Bulgaria, Bulgaria
Stara Zagora, Bulgaria, Bulgaria
Varna, Bulgaria, Bulgaria
Saint John, New Brunswick, Canada
St. John's, Newfoundland and Labrador, Canada
Guelph, Ontario, Canada
Hamilton, Ontario, Canada
Newmarket, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Pointe-Claire, Quebec, Canada
Québec, Quebec, Canada
Québec, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Santiago, Chile, Chile
Vioa Del Mar, Chile, Chile
Rijeka, Croatia, Croatia
Zagreb, Croatia, Croatia
Tartu, Estonia, Estonia
Dieppe, France, France
La Chaussée-Saint-Victor, France, France
Lyon, France, France
Marseille 13, France, France
Nice, France, France
Mannheim, Baden-Wurttemberg, Germany
Munich, Bavaria, Germany
Hamburg, City state of Hamburg, Germany
Dietzenbach, Hesse, Germany
Marburg, Hesse, Germany
Wiesbaden, Hesse, Germany
Dortmund, North Rhine-Westphalia, Germany
Lienen/Kattenve Nne, North Rhine-Westphalia, Germany
Münster, North Rhine-Westphalia, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Budapest, Hungary, Hungary
Dunaújváros, Hungary, Hungary
Kisbér, Hungary, Hungary
Miskolc, Hungary, Hungary
Nagykanizsa, Hungary, Hungary
Nyíregyháza, Hungary, Hungary
Szentes, Hungary, Hungary
Veszprém, Hungary, Hungary
Zalaegerszeg, Hungary, Hungary
Ahmedabad, Gujarat, India
Manipal, Karnataka, India
Bhopal, Madhya Pradesh, India
Aurangabad, Maharashtra, India
Mumbai, Maharashtra, India
Mumbai, Maharashtra, India
Mumbai, Maharashtra, India
Mumbai, Maharashtra, India
Nagpur, Maharashtra, India
Pune, Maharashtra, India
Pune, Maharashtra, India
Pune, Maharashtra, India
Thāne, Maharashtra, India
New Delhi, National Capital Territory of Delhi, India
New Delhi, National Capital Territory of Delhi, India
New Delhi, National Capital Territory of Delhi, India
Ludhiana, Punjab, India
Jaipur, Rajasthan, India
Jaipur, Rajasthan, India
Lucknow, Uttar Pradesh, India
Riga, Latvia, Latvia
Riga, Latvia, Latvia
Countries
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References
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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.
Other Identifiers
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2007-005570-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
E3810-G000-301
Identifier Type: -
Identifier Source: org_study_id