Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
Launched by ASTRAZENECA · Oct 18, 2005
Trial Information
Current as of July 25, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Signed informed consent.
- • Completed the SH-NEN-0001 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 and; Are expected to remain stable for the duration of the study. and; 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- 0001.
- Exclusion Criteria:
- • Discontinuation from study SH-NEN-0001
- • 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.
- • Need for continuous concomitant therapy with: (Anticoagulants; Corticosteroids at doses higher than explained under inclusion criterion)
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
Tucson, Arizona, United States
Anaheim, California, United States
Orange, California, United States
San Francisco, California, United States
Bradenton, Florida, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
West Palm Beach, Florida, United States
Baltimore, Maryland, United States
Winston Salem, North Carolina, United States
Tulsa, Oklahoma, United States
Norfolk, Virginia, United States
Budapest, , Hungary
Berlin, , Germany
Erlangen, , Germany
Virginia Beach, Virginia, United States
Lille, , France
Wiesbaden, , Germany
Barcelona, , Spain
Madrid, , Spain
Regensburg, , Germany
Strasbourg, , France
Genk, , Belgium
Liège, , Belgium
Köln, , Germany
München, , Germany
Sevilla, , Spain
Valencia, , Spain
Zaragoza, , Spain
Lyon, , France
Gent, , Belgium
Guadalajara, , Spain
Dresden, , Germany
Ratingen, , Germany
Szombathely, , Hungary
Palma De Mallorca, , Spain
Conyers, Georgia, United States
Bochum, , Germany
Erfurt, , Germany
Potsdam, , Germany
Zephyr Hills, Florida, United States
Angers, , France
Ribnitz Damgarten, , Germany
Wolmirstedt, , Germany
Szentes, , Hungary
Künzing, , Germany
Newburgh, Indiana, United States
Tipton, Pennsylvania, United States
Ans, , Belgium
Betekom, , Belgium
Braine L 'Alleud, , Belgium
Linkebeek, , Belgium
Massemen, , Belgium
Natoye, , Belgium
Waremme, , Belgium
Zoersel, , Belgium
Mont De Marsan Cedex, , France
Veszprém, , Hungary
Ft. Lauderdale, Florida, United States
South Miami, Florida, United States
Alleur, , Belgium
Beernem, , Belgium
Bottelaere, , Belgium
Buizingen, , Belgium
Duffel, , Belgium
Durnal, , Belgium
Erembodegem, , Belgium
Herentals, , Belgium
Lambermont, , Belgium
Leut, , Belgium
Maasmechelen, , Belgium
Merelbeke, , Belgium
Nivelles, , Belgium
Oud Heverlee, , Belgium
Seraing, , Belgium
Soignies, , Belgium
Vorst (Brussels), , Belgium
Zolder, , Belgium
Albens, , France
Dambach La Ville, , France
Dommartin Les Touls, , France
Fontaine Les Dijon, , France
Gemenos, , France
Geste, , France
Husseren Wesserling, , France
La Regrip, , France
Le Pian Medoc, , France
Maromme, , France
Montingy Les Metz, , France
Paris Cedex 10, , France
Saint Ouen, , France
Tarare, , France
Bernau, , Germany
Dresden Test, , Germany
Genthin, , Germany
Herne, , Germany
Kelkheim, , Germany
Lienen, , Germany
Lüdenscheid, , Germany
Münster, , Germany
Paderborn, , Germany
Passau, , Germany
Saarbrücken, , Germany
Salzgitter, , Germany
Wangen, , Germany
Békéscsaba, , Hungary
Dunaújváros, , Hungary
Vác, , Hungary
Getafe, , Spain
Mérida, , Spain
San Sebastián(guipuzcoa), , Spain
Torrelavega, , Spain
Viladecans, , Spain
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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