Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
Efficacy of Esomeprazole 40 mg Once Daily Versus Placebo or Esomeprazole 20 mg Once Daily Versus Placebo in Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs Including COX-2 Selective NSAIDs
2 other identifiers
interventional
334
6 countries
113
Brief Summary
This study was a multicentre, double-blind, randomised, placebo-controlled parallel group study consisting of 4 visits over a period of 6 months. The primary variable was to assess the efficacy of esomeprazole 40 mg orally qd (E40) or esomeprazole 20 mg orally qd (E20) versus placebo orally qd after 6 months of treatment for the prevention of relapse of upper GI symptoms associated with NSAID use, including COX-2 selective NSAIDs, in patients receiving daily NSAID therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2001
113 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 18, 2005
CompletedFirst Posted
Study publicly available on registry
October 19, 2005
CompletedJanuary 21, 2011
January 1, 2011
2 years
October 18, 2005
January 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
To assess the efficacy of esomeprazole 40 mg orally q.d. versus placebo orally q.d.
and 20 mg q.d. versus placebo orally q.d. through 6 months of treatment for the
prevention of relapse of upper GI symptom associated with NSAID use in patients
receiving daily NSAID therapy.
Secondary Outcomes (1)
To assess the safety and tolerability of esomeprazole 40 mg orally q.d. versus placebo orally q.d. and 20 mg orally q.d. versus placebo orally q.d. when administered for 6 months to patients receiving daily NSAID therapy.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- Hp negative on Histology performed at baseline endoscopy in the study SHNEN- 0001.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (113)
Research Site
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
Related Publications (1)
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.
PMID: 17391505DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Nexium Medical Sciences Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 18, 2005
First Posted
October 19, 2005
Study Start
February 1, 2001
Primary Completion
February 1, 2003
Study Completion
February 1, 2003
Last Updated
January 21, 2011
Record last verified: 2011-01