Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
NCT ID: NCT00241527
Last Updated: 2011-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
556 participants
INTERVENTIONAL
2000-12-31
2002-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Esomeprazole
Eligibility Criteria
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Inclusion Criteria
* 18 years of age, or older.
* Capable of completing the diary card.
* Ability to complete the HRQL questionnaires.
* A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 7 months. Daily NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose aspirin (\>325 mg/day).
* Daily NSAID treatment dose and type: (Must have been stable for at least 4 weeks prior to baseline endoscopy and; Are expected to remain stable for the duration of the study. and; Must be administered orally for the duration of the study. If more than one type of NSAID treatment is used, at least one type must be given orally.)
* Hp negative by UBT, serology or biopsy based test, at visit 1.
Exclusion Criteria
* Current, or history of, esophageal, gastric or duodenal surgery.
* History of GERD, not associated with NSAID use.
* Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation.
* Pain, discomfort or burning in the upper abdomen not associated with the use of NSAIDs, including COX-2 selective NSAIDs, as judged by the investigator.
* Endoscopic Barrett's esophagus(\>3 cm) or significant dysplastic changes in the esophagus.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca Nexium Medical Sciences Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Tallassee, Alabama, United States
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Phoenix, Arizona, United States
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Garden Grove, California, United States
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Orange, California, United States
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Bradenton, Florida, United States
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Coral Gables, Florida, United States
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Hollywood, Florida, United States
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St. Petersburg, Florida, United States
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Tavares, Florida, United States
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Zephyrhills, Florida, United States
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Nampa, Idaho, United States
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Elkhart, Indiana, United States
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Evansville, Indiana, United States
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Newburgh, Indiana, United States
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Wichita, Kansas, United States
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Hollywood, Maryland, United States
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Butte, Montana, United States
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Princeton, New Jersey, United States
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Toms River, New Jersey, United States
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Endwell, New York, United States
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Hewlett, New York, United States
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Charlotte, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Duncansville, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Jackson, Tennessee, United States
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Pasadena, Texas, United States
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Waco, Texas, United States
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Edmonds, Washington, United States
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Olympia, Washington, United States
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Greenfield, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Five Dock, New South Wales, Australia
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Carina Heights, Queensland, Australia
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Kippa-Ring, Queensland, Australia
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Ivanhoe, Victoria, Australia
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Edmonton, Alberta, Canada
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Winnipeg, Manitoba, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Hamilton, Ontario, Canada
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Kitchener, Ontario, Canada
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Newmarket, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Quesnel, , Canada
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St. John's, , Canada
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Ostrava, , Czechia
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Prague, , Czechia
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Bari, BA, Italy
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Genova, GE, Italy
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Milan, MI, Italy
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Perugia, PG, Italy
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Vicenza, VI, Italy
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Napoli, , Italy
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Verona, , Italy
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Bergen, , Norway
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Bodø, , Norway
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Bærum Postterminal, , Norway
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Gjøvik, , Norway
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Horten, , Norway
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Kristiansand, , Norway
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Lillehammer, , Norway
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Nesttun, , Norway
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Oslo, , Norway
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Sandvika, , Norway
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Skien, , Norway
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Stavanger, , Norway
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Tromsø, , Norway
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Bydgoszcz, , Poland
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Sopot, , Poland
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Warsaw, , Poland
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Bratislava, , Slovakia
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Nové Mesto nad Váhom, , Slovakia
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Bloemfontein, , South Africa
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Cape Town, , South Africa
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Johannesburg, , South Africa
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Pretoria, , South Africa
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Bredbyn, , Sweden
Sweden
Gävle, , Sweden
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Karlskrona, , Sweden
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Kungälv, , Sweden
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Lidköping, , Sweden
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Malmo, , Sweden
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Oskarshamn, , Sweden
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Örnsköldsvik, , Sweden
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Östersund, , Sweden
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Rättvik, , Sweden
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Skövde, , Sweden
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Stockholm, , Sweden
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Trehörningsjö, , Sweden
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Trollhättan, , Sweden
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Varberg, , Sweden
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Värnamo, , Sweden
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Västervik, , Sweden
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Reading, Berks, United Kingdom
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Spennymoor, Co. Durham, United Kingdom
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Woking, Surrey, United Kingdom
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Trowbridge, Wiltshire, United Kingdom
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Ashford, , United Kingdom
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Audley, , United Kingdom
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Bath, , United Kingdom
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Bradford Upon Avon, , United Kingdom
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Chesterfield, , United Kingdom
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Coventry, , United Kingdom
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Crawley, , United Kingdom
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Ely, , United Kingdom
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Folkestone, , United Kingdom
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Glasgow, , United Kingdom
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Kilmarnock, , United Kingdom
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Leigh, , United Kingdom
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Mansfield, , United Kingdom
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Nottingham, , United Kingdom
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Pontefract, , United Kingdom
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Royal Tunbridge Wells, , United Kingdom
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Shrewsbury, , United Kingdom
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Stafford, , United Kingdom
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Swansea, , United Kingdom
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Trowbridge, , United Kingdom
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Watford, , United Kingdom
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Wigston, , United Kingdom
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Woking, , United Kingdom
Research Site
Worsley, , United Kingdom
Research Site
Yoxall, , United Kingdom
Countries
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Other Identifiers
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SH-NEN-0003
Identifier Type: -
Identifier Source: secondary_id
D9617C00003
Identifier Type: -
Identifier Source: org_study_id
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