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
276
11 countries
136
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 theefficacy 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 Apr 2001
136 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
April 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 24, 2011
January 1, 2011
1.8 years
October 18, 2005
January 21, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the efficacy of esomeprazole versus placebo through 6 months of treatment for the prevention of relapse of upper GI symptom associated with NSAID use
Secondary Outcomes (1)
To assess the safety & tolerability of esomeprazole versus placebo 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-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:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (136)
Research Site
Tallassee, Alabama, United States
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Phoenix, Arizona, United States
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Garden Grove, California, United States
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Orange, California, United States
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Bradenton, Florida, United States
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Coral Gables, Florida, United States
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Hollywood, Florida, United States
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St. Petersburg, Florida, United States
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Tavares, Florida, United States
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Zephyrhills, Florida, United States
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Nampa, Idaho, United States
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Elkhart, Indiana, United States
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Evansville, Indiana, United States
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Newburgh, Indiana, United States
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Wichita, Kansas, United States
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Hollywood, Maryland, United States
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Butte, Montana, United States
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Princeton, New Jersey, United States
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Toms River, New Jersey, United States
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Endwell, New York, United States
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Hewlett, New York, United States
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Charlotte, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Duncansville, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Jackson, Tennessee, United States
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Waco, Texas, United States
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Edmonds, Washington, United States
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Olympia, Washington, United States
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Greenfield, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Five Dock, New South Wales, Australia
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Various Cities, New South Wales, Australia
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Carina Heights, Queensland, Australia
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Kippa-Ring, Queensland, Australia
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Various Cities, South Australia, Australia
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Various Cities, Tasmania, Australia
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Ivanhoe, Victoria, Australia
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Various Cities, Victoria, Australia
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Edmonton, Alberta, Canada
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Quesnel, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Hamilton, Ontario, Canada
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Kitchener, Ontario, Canada
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Newmarket, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Hlu¿ín, Czechia
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Ostrava, Czechia
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Ostrava - T¿ebovice, Czechia
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Prague, Czechia
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Bari, BA, Italy
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Genova, GE, Italy
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Milan, MI, Italy
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Vicenza, VI, Italy
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Napoli, Italy
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Parma, Italy
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Perugia, Italy
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Verona, Italy
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Bergen, Norway
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Bodø, Norway
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Bærum Postterminal, Norway
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Gjøvik, Norway
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Horten, Norway
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Lillehammer, Norway
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Nesttun, Norway
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Oslo, Norway
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Sandvika, Norway
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Skien, Norway
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Stavanger, Norway
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Tromsø, Norway
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Bia¿ystok, Poland
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Bydgoszcz, Poland
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Sopot, Poland
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Warsaw, Poland
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Wrze¿nia, Poland
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Bratislava, Slovakia
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Nové Mesto nad Váhom, Slovakia
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Pie¿¿any, Slovakia
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Bloemfontein, South Africa
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Cape Town, South Africa
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Johannesburg, South Africa
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Bredbyn, Sweden
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Gävle, Sweden
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Karlskrona, Sweden
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Kungälv, Sweden
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Lidköping, Sweden
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Malmo, Sweden
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Oskarshamn, Sweden
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Örnsköldsvik, Sweden
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Östersund, Sweden
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Rättvik, Sweden
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Skövde, Sweden
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Stockholm, Sweden
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Trehörningsjö, Sweden
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Trollhättan, Sweden
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Varberg, Sweden
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Värnamo, Sweden
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Västervik, Sweden
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Reading, Berks, United Kingdom
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Spennymoor, Co. Durham, United Kingdom
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Woking, Surrey, United Kingdom
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Trowbridge, Wiltshire, United Kingdom
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Ashford, United Kingdom
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Audley, United Kingdom
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Bath, United Kingdom
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Bradford Upon Avon, United Kingdom
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Chesterfield, United Kingdom
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Coventry, United Kingdom
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Crawley, United Kingdom
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Ely, United Kingdom
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Folkestone, United Kingdom
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Glasgow, United Kingdom
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Kilmarnock, United Kingdom
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Leigh, United Kingdom
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Mansfield, United Kingdom
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Nottingham, United Kingdom
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Pontefract, United Kingdom
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Royal Tunbridge Wells, United Kingdom
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Shrewsbury, United Kingdom
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Stafford, United Kingdom
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Swansea, United Kingdom
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Trowbridge, United Kingdom
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Watford, United Kingdom
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Wigston, United Kingdom
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Woking, United Kingdom
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Worsley, United Kingdom
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Yoxall, United Kingdom
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
Interventions
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
April 1, 2001
Primary Completion
February 1, 2003
Study Completion
February 1, 2003
Last Updated
January 24, 2011
Record last verified: 2011-01