Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs

Condition(s) targeted: NSAIDs; Upper GI Symptoms

Intervention: Esomeprazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Nexium Medical Sciences Director, MD, Study Director, Affiliation: AstraZeneca

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.

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study

Primary outcome: 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 outcome: To assess the safety & tolerability of esomeprazole versus placebo when administered for 6 months to patients receiving daily NSAID therapy.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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:

- Must have been stable for at least 9 weeks prior to inclusion

- 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.

Exclusion Criteria:

- 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.

Research Site, Quebec, Canada

Research Site, Ostrava - T¿ebovice, Czech Republic

Research Site, Hlu¿ín, Czech Republic

Research Site, Ostrava, Czech Republic

Research Site, Praha-2, Czech Republic

Research Site, Praha 5, Czech Republic

Research Site, Parma, Italy

Research Site, Perugia, Italy

Research Site, Verona, Italy

Research Site, Napoli, Italy

Research Site, Bærum postterminal, Norway

Research Site, Bergen, Norway

Research Site, Bodø, Norway

Research Site, Gjøvik, Norway

Research Site, Horten, Norway

Research Site, Lillehammer, Norway

Research Site, Nesttun, Norway

Research Site, Oslo, Norway

Research Site, Sandvika, Norway

Research Site, Skien, Norway

Research Site, Stavanger, Norway

Research Site, Tromsø, Norway

Research Site, Bia¿ystok, Poland

Research Site, Bydgoszcz, Poland

Research Site, Sopot, Poland

Research Site, Warszawa, Poland

Research Site, Wrze¿nia, Poland

Research Site, Bratislava, Slovakia

Research Site, Nové Mesto nad Váhom, Slovakia

Research Site, Pie¿¿any, Slovakia

Research Site, Cape Town, South Africa

Research Site, Bloemfontein, South Africa

Research Site, Johannesburg, South Africa

Research Site, Bredbyn, Sweden

Research Site, GÄVLE, Sweden

Research Site, Karlskrona, Sweden

Research Site, Kungälv, Sweden

Research Site, LIDKÖPING, Sweden

Research Site, Malmö, Sweden

Research Site, Örnsköldsvik, Sweden

Research Site, Oskarshamn, Sweden

Research Site, ÖSTERSUND, Sweden

Research Site, Rättvik, Sweden

Research Site, Skövde, Sweden

Research Site, Stockholm, Sweden

Research Site, Trehörningsjö, Sweden

Research Site, Trollhättan, Sweden

Research Site, Varberg, Sweden

Research Site, VÄRNAMO, Sweden

Research Site, VÄSTERVIK, Sweden

Research Site, Ashford, United Kingdom

Research Site, Audley, United Kingdom

Research Site, Bath, United Kingdom

Research Site, Bradford upon Avon, United Kingdom

Research Site, Chesterfield, United Kingdom

Research Site, Coventry, United Kingdom

Research Site, Crawley, United Kingdom

Research Site, Ely, United Kingdom

Research Site, Folkestone, United Kingdom

Research Site, Glasgow, United Kingdom

Research Site, Kilmarnock, United Kingdom

Research Site, Leigh, United Kingdom

Research Site, Mansfield, United Kingdom

Research Site, Nottingham, United Kingdom

Research Site, Pontefract, United Kingdom

Research Site, Shrewsbury, United Kingdom

Research Site, Stafford, United Kingdom

Research Site, Swansea, United Kingdom

Research Site, Trowbridge, United Kingdom

Research Site, Tunbridge Wells, United Kingdom

Research Site, Watford, United Kingdom

Research Site, Wigston, United Kingdom

Research Site, Woking, United Kingdom

Research Site, Worsley, United Kingdom

Research Site, Yoxall, United Kingdom

Research Site, Tallassee, Alabama, United States

Research Site, Edmonton, Alberta, Canada

Research Site, Phoenix, Arizona, United States

Research Site, Bari, BA, Italy

Research Site, Reading, Berks, United Kingdom

Research Site, Quesnel, British Columbia, Canada

Research Site, Garden Grove, California, United States

Research Site, Orange, California, United States

Research Site, Spennymoor, Co. Durham, United Kingdom

Research Site, Bradenton, Florida, United States

Research Site, Coral Gables, Florida, United States

Research Site, Hollywood, Florida, United States

Research Site, St. Petersburg, Florida, United States

Research Site, Tavares, Florida, United States

Research Site, Zephyr Hills, Florida, United States

Research Site, Genova, GE, Italy

Research Site, Nampa, Idaho, United States

Research Site, Elkhart, Indiana, United States

Research Site, Evansville, Indiana, United States

Research Site, Newburgh, Indiana, United States

Research Site, Wichita, Kansas, United States

Research Site, Milano, MI, Italy

Research Site, Winnipeg, Manitoba, Canada

Research Site, Hollywood, Maryland, United States

Research Site, Butte, Montana, United States

Research Site, Princeton, New Jersey, United States

Research Site, Toms River, New Jersey, United States

Research Site, Five Dock, New South Wales, Australia

Research Site, Various Cities, New South Wales, Australia

Research Site, Endwell, New York, United States

Research Site, Hewlett, New York, United States

Research Site, Mount Pearl, Newfoundland and Labrador, Canada

Research Site, St. John's, Newfoundland and Labrador, Canada

Research Site, Charlotte, North Carolina, United States

Research Site, Winston Salem, North Carolina, United States

Research Site, Hamilton, Ontario, Canada

Research Site, Kitchener, Ontario, Canada

Research Site, Newmarket, Ontario, Canada

Research Site, Ottawa, Ontario, Canada

Research Site, Toronto, Ontario, Canada

Research Site, Windsor, Ontario, Canada

Research Site, Duncansville, Pennsylvania, United States

Research Site, Erie, Pennsylvania, United States

Research Site, Montreal, Quebec, Canada

Research Site, Sainte-Foy, Quebec, Canada

Research Site, Sherbrooke, Quebec, Canada

Research Site, Carina Heights, Queensland, Australia

Research Site, Kippa-Ring, Queensland, Australia

Research Site, Saskatoon, Saskatchewan, Canada

Research Site, Various Cities, South Australia, Australia

Research Site, Woking, Surrey, United Kingdom

Research Site, Various Cities, Tasmania, Australia

Research Site, Jackson, Tennessee, United States

Research Site, Waco, Texas, United States

Research Site, Vicenza, VI, Italy

Research Site, Ivanhoe, Victoria, Australia

Research Site, Various Cities, Victoria, Australia

Research Site, Edmonds, Washington, United States

Research Site, Olympia, Washington, United States

Research Site, Trowbridge, Wiltshire, United Kingdom

Research Site, Greenfield, Wisconsin, United States

Research Site, Milwaukee, Wisconsin, United States

Starting date: April 2001
Last updated: October 18, 2005