Clinical trial NCT00241527: Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
Official title: Efficacy of Esomeprazole 40 mg Once Daily Versus Placebo and Esomeprazole 20 mg Once Daily Versus Placebo in Treatment for Relief 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: 556
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 randomised, double-blind, parallel-group and placebo controlled study comparing the efficacy of esomeprazole 40 mg orally qd vs placebo and esomeprazole 20 mg orally qd vs placebo when given to patients on continuous use of NSAIDs, including COX-2 selective NSAIDs, for a treatment period of 4 weeks for relief of upper GI symptoms.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent.
* 18 years of age, or older.
* Capable of completing the diary card.
* Ability to complete the HRQL questionnaires.
* A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 7 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 aspirin (\>325 mg/day).
* Daily NSAID treatment dose and type: (Must have been stable for at least 4 weeks prior to baseline endoscopy and; Are expected to remain stable for the duration of the study. and; Must be administered orally for the duration of the study. If more than one type of NSAID treatment is used, at least one type must be given orally.)
* Hp negative by UBT, serology or biopsy based test, at visit 1.

Exclusion Criteria:

* Current, or history of, gastric or duodenal ulcer
* Current, or history of, esophageal, gastric or duodenal surgery.
* History of GERD, not associated with NSAID use.
* 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, as judged by the investigator.
* Endoscopic Barrett's esophagus(\>3 cm) or significant dysplastic changes in the esophagus.

Primary outcomes:
measure: Mean change in the upper GI symptoms (pain, discomfort or
measure: burning in the upper abdomen), rated on a 7-graded severity scale
Secondary outcomes:
measure: - Mean change in the upper GI symptom score
measure: - The proportion of days with an upper GI symptom score of 'None' at 2 and 4 weeks of treatment.
measure: - Mean upper GI symptom score by day over the duration of the study.
measure: - Cumulative proportion of patients who achieve relief of upper GI symptoms by Week 2 and Week 4.
measure: - Proportions of patients with upper GI symptoms during night, over the duration of the study.
measure: - The proportion of patients with resolution or relief of investigator-recorded symptoms of heartburn, acid regurgitation, nausea & upper abdominal bloating at the 2-week, and 4-week visits.
measure: - The mean change in the three dimensions Reflux, Abdominal pain and Indigestion of the Gastrointestinal Symptom Rating Scale (GSRS)
measure: - Mean change in the three dimensions Emotional distress, Sleep disturbance and Food/Drink problems
measure: - Patient's global evaluation of relief of upper GI symptom (Overall Treatment Evaluation, OTE) at the 2-week, and 4-week visits.
measure: -Short Form-36 (SF-36) score at baseline.
Other outcomes:
Locations:
city: Tallassee
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
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state: Arizona
city: Garden Grove
country: United States
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state: California
city: Orange
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state: California
city: Bradenton
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city: Coral Gables
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city: Hollywood
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city: St Petersburg
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city: Zephyr Hills
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state: Idaho
city: Elkhart
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state: Indiana
city: Evansville
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city: Newburgh
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city: Butte
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city: Princeton
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city: Toms River
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city: Winston-Salem
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city: Erie
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city: Milwaukee
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city: Carina Heights
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city: Kippa Ring
country: Australia
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city: Ivanhoe
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state: Victoria
city: Edmonton
country: Canada
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state: Alberta
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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state: Newfoundland and Labrador
city: Hamilton
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state: Ontario
city: Kitchener
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city: Ottawa
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country: Czech Republic
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city: Bari
country: Italy
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state: BA
city: Genova
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city: Perugia
country: Italy
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city: Vicenza
country: Italy
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city: Napoli
country: Italy
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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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country: Norway
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country: Norway
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country: Norway
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country: Norway
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country: Norway
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city: Oslo
country: Norway
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country: Norway
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country: Norway
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country: Norway
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country: Norway
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country: Poland
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country: Poland
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country: Poland
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country: Slovakia
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city: Nové Mesto nad Váhom
country: Slovakia
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city: Bloemfontein
country: South Africa
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city: Cape Town
country: South Africa
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city: Johannesburg
country: South Africa
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city: Pretoria
country: South Africa
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city: Bredbyn
country: Sweden
facility: Research Site
city: Gävle
country: Sweden
facility: Sweden
city: Karlskrona
country: Sweden
facility: Research Site
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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country: Sweden
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country: Sweden
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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
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city: Östersund
country: Sweden
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city: Reading
country: United Kingdom
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state: Berks
city: Spennymoor
country: United Kingdom
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state: Co. Durham
city: Woking
country: United Kingdom
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state: Surrey
city: Trowbridge
country: United Kingdom
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state: Wiltshire
city: Ashford
country: United Kingdom
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city: Audley
country: United Kingdom
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city: Bath
country: United Kingdom
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city: Bradford upon Avon
country: United Kingdom
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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
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city: Folkestone
country: United Kingdom
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city: Glasgow
country: United Kingdom
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city: Kilmarnock
country: United Kingdom
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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
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city: Stafford
country: United Kingdom
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city: Swansea
country: United Kingdom
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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: