Upper-GI Symptoms Clinical Trial
— NSAIDS IIOfficial title:
Upper GI Symptoms In Patients Receiving Acetylsalicylic Acid/NSAIDs - NSAIDs Wave 2
| Verified date | January 2009 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Greece: National Organization of Medicines |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 850 |
| Est. completion date | December 2008 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| Greece | Research Site | Agrinio | |
| Greece | Research Site | Alexandroupoli | |
| Greece | Research Site | Argostoli | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Chalkida | |
| Greece | Research Site | Drama | |
| Greece | Research Site | Heraklion | |
| Greece | Research Site | Ioannina | |
| Greece | Research Site | Kalamata | |
| Greece | Research Site | Kallikratia | |
| Greece | Research Site | Katerini | |
| Greece | Research Site | Kiato | |
| Greece | Research Site | Komotini | |
| Greece | Research Site | Korinthos | |
| Greece | Research Site | Kozani | |
| Greece | Research Site | Lamia | |
| Greece | Research Site | Larisa | |
| Greece | Research Site | Patra | |
| Greece | Research Site | Peireous | |
| Greece | Research Site | Pirgos | |
| Greece | Research Site | Preveza | |
| Greece | Research Site | Rethimnon | |
| Greece | Research Site | Serres | |
| Greece | Research Site | Thessaloniki | |
| Greece | Research Site | Tripoli | |
| Greece | Research Site | Volos | |
| Greece | Research Site | Xania |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Greece,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Frequency (%) of patients in the Greek Primary Practice, presenting Upper GI Symptoms while receiving NSAIDS treatment with/without gastroprotective measures. | Single visit / once | ||
| Secondary | The nature of upper GI symptoms (Dyspepsia and GERD) experienced by patients receiving acetylsalicylic acid and / or NSAIDS treatment | single visit / once | ||
| Secondary | To determine the main indications for acetylsalicylic acid and or NSAIDS prescription among GPs and specialized private doctors in Greece. | single visit / once |