Clinical trial NCT00241553: Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: NSAIDs
Upper GI Symptoms
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-19
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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:
measure: To assess the safety & tolerability of esomeprazole versus placebo when administered for 6 months to patients receiving daily NSAID therapy.
Other outcomes:
Locations:
city: Tallassee
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Garden Grove
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: Bradenton
country: United States
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state: Florida
city: Coral Gables
country: United States
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state: Florida
city: Hollywood
country: United States
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state: Florida
city: St Petersburg
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city: Tavares
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city: Zephyr Hills
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city: Butte
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state: Montana
city: Princeton
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city: Toms River
country: United States
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city: Hewlett
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city: Charlotte
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city: Winston-Salem
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city: Erie
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city: Olympia
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city: Milwaukee
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state: New South Wales
city: Various Cities
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city: Carina Heights
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city: Kippa Ring
country: Australia
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city: Various Cities
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state: Tasmania
city: Ivanhoe
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state: Victoria
city: Various Cities
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state: Victoria
city: Edmonton
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state: Alberta
city: Quesnel
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state: British Columbia
city: Winnipeg
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state: Manitoba
city: Mount Pearl
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state: Newfoundland and Labrador
city: St. John's
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city: Hamilton
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state: Ontario
city: Kitchener
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city: Newmarket
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city: Sainte-Foy
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city: Sherbrooke
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state: Quebec
city: Saskatoon
country: Canada
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state: Saskatchewan
city: Quebec
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facility: Research Site
city: Hlu¿ín
country: Czech Republic
facility: Research Site
city: Ostrava - T¿ebovice
country: Czech Republic
facility: Research Site
city: Ostrava
country: Czech Republic
facility: Research Site
city: Praha 2
country: Czech Republic
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city: Praha 5
country: Czech Republic
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city: Bari
country: Italy
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state: BA
city: Genova
country: Italy
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state: GE
city: Milano
country: Italy
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state: MI
city: Vicenza
country: Italy
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state: VI
city: Napoli
country: Italy
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city: Parma
country: Italy
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city: Perugia
country: Italy
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city: Verona
country: Italy
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city: Bergen
country: Norway
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city: Bodø
country: Norway
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city: Bærum postterminal
country: Norway
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city: Gjøvik
country: Norway
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city: Horten
country: Norway
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city: Lillehammer
country: Norway
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city: Nesttun
country: Norway
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city: Oslo
country: Norway
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city: Sandvika
country: Norway
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city: Skien
country: Norway
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city: Stavanger
country: Norway
facility: Research Site
city: Tromsø
country: Norway
facility: Research Site
city: Bia¿ystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Sopot
country: Poland
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city: Warszawa
country: Poland
facility: Research Site
city: Wrze¿nia
country: Poland
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Nové Mesto nad Váhom
country: Slovakia
facility: Research Site
city: Pie¿¿any
country: Slovakia
facility: Research Site
city: Bloemfontein
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Bredbyn
country: Sweden
facility: Research Site
city: Gävle
country: Sweden
facility: Research Site
city: Karlskrona
country: Sweden
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city: Kungälv
country: Sweden
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city: Lidköping
country: Sweden
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city: Malmö
country: Sweden
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city: Oskarshamn
country: Sweden
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city: Rättvik
country: Sweden
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city: Skövde
country: Sweden
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city: Stockholm
country: Sweden
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city: Trehörningsjö
country: Sweden
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city: Trollhättan
country: Sweden
facility: Research Site
city: Varberg
country: Sweden
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city: Värnamo
country: Sweden
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city: Västervik
country: Sweden
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city: Örnsköldsvik
country: Sweden
facility: Research Site
city: Östersund
country: Sweden
facility: Research Site
city: Reading
country: United Kingdom
facility: Research Site
state: Berks
city: Spennymoor
country: United Kingdom
facility: Research Site
state: Co. Durham
city: Woking
country: United Kingdom
facility: Research Site
state: Surrey
city: Trowbridge
country: United Kingdom
facility: Research Site
state: Wiltshire
city: Ashford
country: United Kingdom
facility: Research Site
city: Audley
country: United Kingdom
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city: Bath
country: United Kingdom
facility: Research Site
city: Bradford upon Avon
country: United Kingdom
facility: Research Site
city: Chesterfield
country: United Kingdom
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city: Coventry
country: United Kingdom
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city: Crawley
country: United Kingdom
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city: Ely
country: United Kingdom
facility: Research Site
city: Folkestone
country: United Kingdom
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city: Glasgow
country: United Kingdom
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city: Kilmarnock
country: United Kingdom
facility: Research Site
city: Leigh
country: United Kingdom
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city: Mansfield
country: United Kingdom
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city: Nottingham
country: United Kingdom
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city: Pontefract
country: United Kingdom
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city: Shrewsbury
country: United Kingdom
facility: Research Site
city: Stafford
country: United Kingdom
facility: Research Site
city: Swansea
country: United Kingdom
facility: Research Site
city: Trowbridge
country: United Kingdom
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city: Tunbridge Wells
country: United Kingdom
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city: Watford
country: United Kingdom
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city: Wigston
country: United Kingdom
facility: Research Site
city: Woking
country: United Kingdom
facility: Research Site
city: Worsley
country: United Kingdom
facility: Research Site
city: Yoxall
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Nexium Medical Sciences Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.