- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00691743
Upper GI Symptoms In Patients Receiving Acetylsalicylic Acid/NSAIDs - NSAIDs Wave 2 (NSAIDS II)
January 9, 2009 updated by: AstraZeneca
The current epidemiological study will be undertaken in GP's and specialized private doctors.
In total, 85 general practitioners, orthopedics, rheumatologists and cardiologist will take part in the study.
Data will be collected for 850 patients who visit their physician for medical conditions that require the use of acetylsalicylic acid and/or NSAIDS.
The first 10 consecutive patients who visit their GP/orthopedic/rheumatologist/cardiologists and are currently receiving acetylsalicylic acid and/or NSAIDS will be included in the study.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
850
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Agrinio, Greece
- Research Site
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Alexandroupoli, Greece
- Research Site
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Argostoli, Greece
- Research Site
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Athens, Greece
- Research Site
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Chalkida, Greece
- Research Site
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Drama, Greece
- Research Site
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Heraklion, Greece
- Research Site
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Ioannina, Greece
- Research Site
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Kalamata, Greece
- Research Site
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Kallikratia, Greece
- Research Site
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Katerini, Greece
- Research Site
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Kiato, Greece
- Research Site
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Komotini, Greece
- Research Site
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Korinthos, Greece
- Research Site
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Kozani, Greece
- Research Site
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Lamia, Greece
- Research Site
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Larisa, Greece
- Research Site
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Patra, Greece
- Research Site
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Peireous, Greece
- Research Site
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Pirgos, Greece
- Research Site
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Preveza, Greece
- Research Site
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Rethimnon, Greece
- Research Site
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Serres, Greece
- Research Site
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Thessaloniki, Greece
- Research Site
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Tripoli, Greece
- Research Site
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Volos, Greece
- Research Site
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Xania, Greece
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Primary care
Description
Inclusion Criteria:
- Acetylsalicylic acid/NSAIDS intake for at least 5 days of a week during the past month before the patient's visit to the clinician
Exclusion Criteria:
- Patients who are not willing to sign of the Informed Consent Form
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Primary care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Frequency (%) of patients in the Greek Primary Practice, presenting Upper GI Symptoms while receiving NSAIDS treatment with/without gastroprotective measures.
Time Frame: Single visit / once
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Single visit / once
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The nature of upper GI symptoms (Dyspepsia and GERD) experienced by patients receiving acetylsalicylic acid and / or NSAIDS treatment
Time Frame: single visit / once
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single visit / once
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To determine the main indications for acetylsalicylic acid and or NSAIDS prescription among GPs and specialized private doctors in Greece.
Time Frame: single visit / once
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single visit / once
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rokkas Theodoros, MD, Errikos Ntinan Hospital, Athens, Greece
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Study Completion (ACTUAL)
December 1, 2008
Study Registration Dates
First Submitted
June 3, 2008
First Submitted That Met QC Criteria
June 4, 2008
First Posted (ESTIMATE)
June 5, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
January 12, 2009
Last Update Submitted That Met QC Criteria
January 9, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-GGR-DUM-2008/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.