NSAIDsPhase 3NCT00241527
Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
A Phase 3 study testing Esomeprazole in people with NSAIDs and Upper GI Symptoms, run by AstraZeneca at 130 sites in 11 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSAIDs, Upper GI Symptoms
- What is being tested?
- Esomeprazole
- How many people
- 556 participants
- Where
- 130 sitesin 11 countries
- Study dates
- Dec 2000to Sep 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
130 sites in 11 countries.
130 sites in 11 countries
United States32 sites
Research Site
Bradenton, Florida
Research Site
Butte, Montana
Research Site
Charlotte, North Carolina
Research Site
Coral Gables, Florida
Research Site
Duncansville, Pennsylvania
Research Site
Edmonds, Washington
Research Site
Elkhart, Indiana
Research Site
Endwell, New York
Research Site
Erie, Pennsylvania
Research Site
Evansville, Indiana
Research Site
Garden Grove, California
Research Site
Greenfield, Wisconsin
Research Site
Hewlett, New York
Research Site
Hollywood, Florida
Research Site
Hollywood, Maryland
Research Site
Jackson, Tennessee
Research Site
Milwaukee, Wisconsin
Research Site
Nampa, Idaho
Research Site
Newburgh, Indiana
Research Site
Olympia, Washington
Research Site
Orange, California
Research Site
Pasadena, Texas
Research Site
Phoenix, Arizona
Research Site
Princeton, New Jersey
Research Site
St. Petersburg, Florida
Research Site
Tallassee, Alabama
Research Site
Tavares, Florida
Research Site
Toms River, New Jersey
Research Site
Waco, Texas
Research Site
Wichita, Kansas
Research Site
Winston-Salem, North Carolina
Research Site
Zephyrhills, Florida
United Kingdom29 sites
Research Site
Ashford
Research Site
Audley
Research Site
Bath
Research Site
Bradford Upon Avon
Research Site
Chesterfield
Research Site
Coventry
Research Site
Crawley
Research Site
Ely
Research Site
Folkestone
Research Site
Glasgow
Research Site
Kilmarnock
Research Site
Leigh
Research Site
Mansfield
Research Site
Nottingham
Research Site
Pontefract
Research Site
Reading, Berks
Research Site
Royal Tunbridge Wells
Research Site
Shrewsbury
Research Site
Spennymoor, Co. Durham
Research Site
Stafford
Research Site
Swansea
Research Site
Trowbridge, Wiltshire
Research Site
Trowbridge
Research Site
Watford
Research Site
Wigston
Research Site
Woking, Surrey
Research Site
Woking
Research Site
Worsley
Research Site
Yoxall
Canada17 sites
Research Site
Edmonton, Alberta
Research Site
Hamilton, Ontario
Research Site
Kitchener, Ontario
Research Site
Montreal, Quebec
Research Site
Mount Pearl, Newfoundland and Labrador
Research Site
Newmarket, Ontario
Research Site
Ottawa, Ontario
Research Site
Québec, Quebec
Research Site
Quesnel
Research Site
Sainte-Foy, Quebec
Research Site
Saskatoon, Saskatchewan
Research Site
Sherbrooke, Quebec
Research Site
St. John's, Newfoundland and Labrador
Research Site
St. John's
Research Site
Toronto, Ontario
Research Site
Windsor, Ontario
Research Site
Winnipeg, Manitoba
Sweden17 sites
Research Site
Bredbyn
Sweden
Gävle
Research Site
Karlskrona
Research Site
Kungälv
Research Site
Lidköping
Research Site
Malmö
Research Site
Örnsköldsvik
Research Site
Oskarshamn
Research Site
Östersund
Research Site
Rättvik
Research Site
Skövde
Research Site
Stockholm
Research Site
Trehörningsjö
Research Site
Trollhättan
Research Site
Varberg
Research Site
Värnamo
Research Site
Västervik
Norway13 sites
Research Site
Bærum Postterminal
Research Site
Bergen
Research Site
Bodø
Research Site
Gjøvik
Research Site
Horten
Research Site
Kristiansand
Research Site
Lillehammer
Research Site
Nesttun
Research Site
Oslo
Research Site
Sandvika
Research Site
Skien
Research Site
Stavanger
Research Site
Tromsø
Italy7 sites
Research Site
Bari, BA
Research Site
Genova, GE
Research Site
Milan, MI
Research Site
Naples
Research Site
Perugia, PG
Research Site
Verona
Research Site
Vicenza, VI
Australia4 sites
Research Site
Carina Heights, Queensland
Research Site
Five Dock, New South Wales
Research Site
Ivanhoe, Victoria
Research Site
Kippa-Ring, Queensland
South Africa4 sites
Research Site
Bloemfontein
Research Site
Cape Town
Research Site
Johannesburg
Research Site
Pretoria
About this study
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
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.
- Conditions
- NSAIDs, Upper GI Symptoms
- Being tested
- Esomeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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.
- The mean change in the three dimensions Reflux, Abdominal pain and Indigestion of the Gastrointestinal Symptom Rating Scale (GSRS)
- Mean change in the three dimensions Emotional distress, Sleep disturbance and Food/Drink problems
- Patient's global evaluation of relief of upper GI symptom (Overall Treatment Evaluation, OTE) at the 2-week, and 4-week visits.
-Short Form-36 (SF-36) score at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
- Study startDec 2000
- Primary completionSep 2002
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSAIDsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 556 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Nexium Medical Sciences Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241527
- Sponsor's protocol ID
- D9617C00003
- Other IDs
- SH-NEN-0003
- Status last verified
- Jan 2011
- First submitted
- 18 Oct 2005
- Last updated
- 24 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00241527
- Acronym / sponsor ID
- D9617C00003
- Conditions
- NSAIDs, Upper GI Symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 556 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2000
- Primary completion
- Sep 2002 (actual)
- Study completion
- Sep 2002 (actual)
- First posted
- 19 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esomeprazole | Drug | – |
Primary outcome
Mean change in the upper GI symptoms (pain, discomfort or
burning in the upper abdomen), rated on a 7-graded severity scale
10 secondary outcomes
- 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.
- 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.
- The mean change in the three dimensions Reflux, Abdominal pain and Indigestion of the Gastrointestinal Symptom Rating Scale (GSRS)
- Mean change in the three dimensions Emotional distress, Sleep disturbance and Food/Drink problems
- Patient's global evaluation of relief of upper GI symptom (Overall Treatment Evaluation, OTE) at the 2-week, and 4-week visits.
-Short Form-36 (SF-36) score at baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca Nexium Medical Sciences Director, MD study director
AstraZeneca
130 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Esomeprazole in people with NSAIDs and Upper GI Symptoms, run by AstraZeneca at 130 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 130 sites in United States, United Kingdom, Canada, Sweden, Norway and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in the upper GI symptoms (pain, discomfort or. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2011.