Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
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
2 other identifiers
interventional
556
11 countries
130
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2000
130 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2002
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 (2)
Mean change in the upper GI symptoms (pain, discomfort or
burning in the upper abdomen), rated on a 7-graded severity scale
Secondary Outcomes (10)
- Mean change in the upper GI symptom score
- The proportion of days with an upper GI symptom score of 'None' at 2 and 4 weeks of treatment.
- Mean upper GI symptom score by day over the duration of the study.
- Cumulative proportion of patients who achieve relief of upper GI symptoms by Week 2 and Week 4.
- Proportions of patients with upper GI symptoms during night, over the duration of the study.
- +5 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (130)
Research Site
Tallassee, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Garden Grove, California, United States
Research Site
Orange, California, United States
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
Zephyrhills, Florida, United States
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
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
Endwell, New York, United States
Research Site
Hewlett, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Duncansville, Pennsylvania, United States
Research Site
Erie, Pennsylvania, United States
Research Site
Jackson, Tennessee, United States
Research Site
Pasadena, Texas, United States
Research Site
Waco, Texas, United States
Research Site
Edmonds, Washington, United States
Research Site
Olympia, Washington, United States
Research Site
Greenfield, Wisconsin, United States
Research Site
Milwaukee, Wisconsin, United States
Research Site
Five Dock, New South Wales, Australia
Research Site
Carina Heights, Queensland, Australia
Research Site
Kippa-Ring, Queensland, Australia
Research Site
Ivanhoe, Victoria, Australia
Research Site
Edmonton, Alberta, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Mount Pearl, Newfoundland and Labrador, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
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
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Sainte-Foy, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada
Research Site
Saskatoon, Saskatchewan, Canada
Research Site
Quesnel, Canada
Research Site
St. John's, Canada
Research Site
Ostrava, Czechia
Research Site
Prague, Czechia
Research Site
Bari, BA, Italy
Research Site
Genova, GE, Italy
Research Site
Milan, MI, Italy
Research Site
Perugia, PG, Italy
Research Site
Vicenza, VI, Italy
Research Site
Napoli, Italy
Research Site
Verona, Italy
Research Site
Bergen, Norway
Research Site
Bodø, Norway
Research Site
Bærum Postterminal, Norway
Research Site
Gjøvik, Norway
Research Site
Horten, Norway
Research Site
Kristiansand, 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
Bydgoszcz, Poland
Research Site
Sopot, Poland
Research Site
Warsaw, Poland
Research Site
Bratislava, Slovakia
Research Site
Nové Mesto nad Váhom, Slovakia
Research Site
Bloemfontein, South Africa
Research Site
Cape Town, South Africa
Research Site
Johannesburg, South Africa
Research Site
Pretoria, South Africa
Research Site
Bredbyn, Sweden
Sweden
Gävle, Sweden
Research Site
Karlskrona, Sweden
Research Site
Kungälv, Sweden
Research Site
Lidköping, Sweden
Research Site
Malmo, Sweden
Research Site
Oskarshamn, Sweden
Research Site
Örnsköldsvik, 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
Reading, Berks, United Kingdom
Research Site
Spennymoor, Co. Durham, United Kingdom
Research Site
Woking, Surrey, United Kingdom
Research Site
Trowbridge, Wiltshire, United Kingdom
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
Royal Tunbridge Wells, United Kingdom
Research Site
Shrewsbury, United Kingdom
Research Site
Stafford, United Kingdom
Research Site
Swansea, United Kingdom
Research Site
Trowbridge, 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
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
December 1, 2000
Primary Completion
September 1, 2002
Study Completion
September 1, 2002
Last Updated
January 24, 2011
Record last verified: 2011-01