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: NCT00658775
Last Updated: 2015-12-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1069 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, once daily for 4-8 weeks.
2
Esomeprazole
Esomeprazole 40 mg capsule, once daily for 4-8 weeks.
Interventions
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Rabeprazole sodium
Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks.
Esomeprazole
Esomeprazole 40 mg capsule, 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 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.
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).
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
Role: STUDY_DIRECTOR
Eisai Inc.
Locations
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Moline, Illinois, United States
La Plata, Argentina, Argentina
Buenos Aires, BUE, Argentina
Buenos Aires, BUE, Argentina
Ciudad Autonoma de Bs. As., CBA, Argentina
Ciudad Autonoma de Bs. As., CBA, Argentina
Ciudad Autonoma de Bs. As., CBA, Argentina
Rosario, SFE, Argentina
San Miguel de Tucumán, TUC, Argentina
Penrith, New South Wales, Australia
Caboolture, Queensland, Australia
Adelaide, South Australia, Australia
Woodville, South Australia, Australia
Launceston, Tasmania, Australia
Ballarat, Victoria, Australia
Fitzroy, Victoria, Australia
Haskovo, Bulgaria, Bulgaria
Plovdiv, Bulgaria, Bulgaria
Rousse, Bulgaria, Bulgaria
Sofia, Bulgaria, Bulgaria
Sofia, Bulgaria, Bulgaria
Barrie, Ontario, Canada
Chatham, Ontario, Canada
Hamilton, Ontario, Canada
Richmond Hill, Ontario, Canada
Sarnia, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Sherbrooke, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Providencia, Chile, Chile
Santiago, Chile, Chile
Temuco, Chile, Chile
Osijek, Croatia, Croatia
Split, Croatia, Croatia
Zagreb, Croatia, Croatia
Tallinn, Estonia, Estonia
Tallinn, Estonia, Estonia
Saint-Quentin, France, France
Lyon, Lyonnais, France
Marseille, Provence-Alpes-Côte d'Azur Region, France
Freising, Bavaria, Germany
Potsdam, BR, Germany
Herne, North Rhine-Westphalia, Germany
Münster, North Rhine-Westphalia, Germany
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Mainz, Rhineland-Palatinate, Germany
Dresden, Saxony, Germany
Wolmirstedt, Saxony-Anhalt, Germany
Balatonfüred, Hungary, Hungary
Budapest, Hungary, Hungary
Budapest, Hungary, Hungary
Debrecen, Hungary, Hungary
Eger, Hungary, Hungary
Győr, Hungary, Hungary
Gyula, Hungary, Hungary
Kaposvár, Hungary, Hungary
Pécs, Hungary, Hungary
Siófok, Hungary, Hungary
Szekszárd, Hungary, Hungary
Hyderabad, Andhra Pradesh, India
Hyderabad, Andhra Pradesh, India
Hyderabad, Andhra Pradesh, India
Hyderabad, Andhra Pradesh, India
Hyderabad, Andhra Pradesh, India
Hyderabad, Andhra Pradesh, India
Secunderabad, Andhra Pradesh, India
Visakhapatnam, Andhra Pradesh, India
Bangalore, Karnataka, India
Mangalore, Karnataka, India
Kochi, Kerala, India
New Delhi, National Capital Territory of Delhi, India
Ludhiana, Punjab, India
Chennai, Tamil Nadu, India
Madurai, Tamil Nadu, India
Balvi, Latvia, Latvia
Daugavpils, Latvia, Latvia
Riga, Latvia, Latvia
Šiauliai, Lithuania, Lithuania
Vilnius, Lithuania, Lithuania
Vilnius, Lithuania, Lithuania
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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2007-006046-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
E3810-G000-302
Identifier Type: -
Identifier Source: org_study_id