Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
Launched by ASTRAZENECA · Oct 18, 2005
Trial Information
Current as of May 08, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Signed informed consent.
- • Completed the SH-NEN-0003 study with relief of upper GI symptom. Relief is defined as "last 7 days with a diary assessment of None or Minimal, but allowing up to 2 days to be rated as Mild during the 7-day period".
- • A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 6 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 NSAIDs.
- * Daily NSAID treatment dose and type:
- • Must have been stable for at least 9 weeks prior to inclusion
- • Are expected to remain stable for the duration of the study.
- • Must be administered orally. If more than one type of NSAID treatment is used, at least one type must be administered orally.
- • Hp negative on Histology performed at baseline endoscopy in the study SHNEN-0003.
- Exclusion Criteria:
- • Discontinuation from study SH-NEN-0003
- • 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.
- • Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator.
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Phoenix, Arizona, United States
Orange, California, United States
Bradenton, Florida, United States
Tavares, Florida, United States
Evansville, Indiana, United States
Jackson, Mississippi, United States
Princeton, New Jersey, United States
Charlotte, North Carolina, United States
Winston Salem, North Carolina, United States
Erie, Pennsylvania, United States
Waco, Texas, United States
Olympia, Washington, United States
Milwaukee, Wisconsin, United States
Edmonton, Alberta, Canada
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Ostrava, , Czech Republic
Bloemfontein, , South Africa
Cape Town, , South Africa
Johannesburg, , South Africa
Toms River, New Jersey, United States
Kitchener, , Canada
Quebec, , Canada
Warszawa, , Poland
Glasgow, , United Kingdom
Winnipeg, Manitoba, Canada
St. John's, Newfoundland And Labrador, Canada
Newmarket, Ontario, Canada
Ottawa, Ontario, Canada
Windsor, Ontario, Canada
Stockholm, , Sweden
Nottingham, , United Kingdom
Bari, Ba, Italy
Napoli, , Italy
Skövde, , Sweden
östersund, , Sweden
Garden Grove, California, United States
Wichita, Kansas, United States
Praha 2, , Czech Republic
Bergen, , Norway
Oslo, , Norway
Bydgoszcz, , Poland
Butte, Montana, United States
Perugia, , Italy
Genova, , Italy
Skien, , Norway
Bratislava, , Slovakia
Sopot, , Poland
Lillehammer, , Norway
Stavanger, , Norway
Sherbrooke, Quebec, Canada
Praha 5, , Czech Republic
Bia¿Ystok, , Poland
Zephyr Hills, Florida, United States
Duncansville, Pennsylvania, United States
Malmö, , Sweden
Saskatoon, Saskatchewan, Canada
Parma, , Italy
Bodø, , Norway
Gjøvik, , Norway
Nesttun, , Norway
Tromsø, , Norway
Karlskrona, , Sweden
Kungälv, , Sweden
Varberg, , Sweden
Värnamo, , Sweden
Ashford, , United Kingdom
Coventry, , United Kingdom
Stafford, , United Kingdom
Oskarshamn, , Sweden
Västervik, , Sweden
Horten, , Norway
Hollywood, Florida, United States
Bath, , United Kingdom
Newburgh, Indiana, United States
Mount Pearl, Newfoundland And Labrador, Canada
Milano, Mi, Italy
Gävle, , Sweden
Trollhättan, , Sweden
Kilmarnock, , United Kingdom
Tallassee, Alabama, United States
Coral Gables, Florida, United States
St Petersburg, Florida, United States
Nampa, Idaho, United States
Elkhart, Indiana, United States
Endwell, New York, United States
Hewlett, New York, United States
Edmonds, Washington, United States
Greenfield, Wisconsin, United States
Five Dock, New South Wales, Australia
Carina Heights, Queensland, Australia
Kippa Ring, Queensland, Australia
Ivanhoe, Victoria, Australia
Sainte Foy, Quebec, Canada
Quesnel, , Canada
Vicenza, Vi, Italy
Verona, , Italy
Bærum Postterminal, , Norway
Sandvika, , Norway
Nové Mesto Nad Váhom, , Slovakia
Bredbyn, , Sweden
Lidköping, , Sweden
Rättvik, , Sweden
Trehörningsjö, , Sweden
örnsköldsvik, , Sweden
Reading, Berks, United Kingdom
Spennymoor, Co. Durham, United Kingdom
Woking, Surrey, United Kingdom
Trowbridge, Wiltshire, United Kingdom
Audley, , United Kingdom
Bradford Upon Avon, , United Kingdom
Chesterfield, , United Kingdom
Crawley, , United Kingdom
Ely, , United Kingdom
Folkestone, , United Kingdom
Leigh, , United Kingdom
Mansfield, , United Kingdom
Pontefract, , United Kingdom
Shrewsbury, , United Kingdom
Swansea, , United Kingdom
Tunbridge Wells, , United Kingdom
Watford, , United Kingdom
Wigston, , United Kingdom
Worsley, , United Kingdom
Yoxall, , United Kingdom
Various Cities, New South Wales, Australia
Hlu¿ín, , Czech Republic
Ostrava T¿Ebovice, , Czech Republic
Wrze¿Nia, , Poland
Pie¿¿Any, , Slovakia
Patients applied
Trial Officials
AstraZeneca Nexium Medical Sciences Director, MD
Study Director
AstraZeneca
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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