Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
NCT ID: NCT00241514
Last Updated: 2011-01-21
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
334 participants
INTERVENTIONAL
2001-02-28
2003-02-28
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
* 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
* 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)
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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Tucson, Arizona, United States
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Anaheim, California, United States
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Orange, California, United States
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San Francisco, California, United States
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Bradenton, Florida, United States
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Clearwater, Florida, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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South Miami, Florida, United States
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West Palm Beach, Florida, United States
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Zephyrhills, Florida, United States
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Conyers, Georgia, United States
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Newburgh, Indiana, United States
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Baltimore, Maryland, United States
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Winston-Salem, North Carolina, United States
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Tulsa, Oklahoma, United States
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Tipton, Pennsylvania, United States
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Norfolk, Virginia, United States
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Virginia Beach, Virginia, United States
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Alleur, , Belgium
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Ans, , Belgium
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Beernem, , Belgium
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Betekom, , Belgium
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Bottelare, , Belgium
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Braine-l'Alleud, , Belgium
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Buizingen, , Belgium
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Duffel, , Belgium
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Durnal, , Belgium
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Erembodegem, , Belgium
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Genk, , Belgium
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Ghent, , Belgium
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Herentals, , Belgium
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Lambermont, , Belgium
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Leut, , Belgium
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Liège, , Belgium
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Linkebeek, , Belgium
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Maasmechelen, , Belgium
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Massemen, , Belgium
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Merelbeke, , Belgium
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Natoye, , Belgium
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Nivelles, , Belgium
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Oud-Heverlee, , Belgium
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Seraing, , Belgium
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Soignies, , Belgium
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Vorst (Brussels), , Belgium
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Waremme, , Belgium
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Zoersel, , Belgium
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Zolder, , Belgium
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Albens, , France
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Angers, , France
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Dambach-la-Ville, , France
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Dommartin-les-touls, , France
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Fontaine-lès-Dijon, , France
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Gesté, , France
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Gémenos, , France
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Husseren-Wesserling, , France
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La Regrip, , France
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Le Pian-Médoc, , France
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Lille, , France
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Lyon, , France
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Maromme, , France
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Mont-de-Marsan, , France
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Montingy Les Metz, , France
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Paris, , France
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Saint-Ouen, , France
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Strasbourg, , France
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Tarare, , France
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Berlin, , Germany
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Bernau, , Germany
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Bochum, , Germany
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Cologne, , Germany
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Dresden, , Germany
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Dresden-Test, , Germany
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Erfurt, , Germany
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Erlangen, , Germany
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Genthin, , Germany
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Herne, , Germany
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Kelkheim, , Germany
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Künzing, , Germany
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Lienen, , Germany
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Lüdenscheid, , Germany
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München, , Germany
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Münster, , Germany
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Paderborn, , Germany
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Passau, , Germany
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Potsdam, , Germany
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Ratingen, , Germany
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Regensburg, , Germany
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Ribnitz-Damgarten, , Germany
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Saarbrücken, , Germany
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Salzgitter, , Germany
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Wangen, , Germany
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Wiesbaden, , Germany
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Wolmirstedt, , Germany
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Békéscsaba, , Hungary
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Budapest, , Hungary
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Dunaújváros, , Hungary
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Szentes, , Hungary
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Szombathely, , Hungary
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Vác, , Hungary
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Veszprém, , Hungary
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Barcelona, , Spain
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Getafe, , Spain
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Guadalajara, , Spain
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Madrid, , Spain
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Mérida, , Spain
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Palma de Mallorca, , Spain
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San Sebastián(Guipuzcoa), , Spain
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Seville, , Spain
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Torrelavega, , Spain
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Valencia, , Spain
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Viladecans, , Spain
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Zaragoza, , Spain
Countries
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References
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Hawkey CJ, Talley NJ, Scheiman JM, Jones RH, Langstrom G, Naesdal J, Yeomans ND; NASA/SPACE author group. Maintenance treatment with esomeprazole following initial relief of non-steroidal anti-inflammatory drug-associated upper gastrointestinal symptoms: the NASA2 and SPACE2 studies. Arthritis Res Ther. 2007;9(1):R17. doi: 10.1186/ar2124.
Other Identifiers
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SH-NEN-0002
Identifier Type: -
Identifier Source: secondary_id
D9617C00002
Identifier Type: -
Identifier Source: org_study_id
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