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Search / Trial NCT00241514

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 24, 2025

Completed

Keywords

Nsai Ds Upper Gi Symptoms

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.

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

0 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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