Upper GI Symptoms In Patients Receiving Acetylsalicylic Acid/NSAIDs - NSAIDs Wave 2 (NSAIDS II)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00691743
First received: June 3, 2008
Last updated: January 9, 2009
Last verified: January 2009
  Purpose

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.


Condition
Upper-GI Symptoms

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Upper GI Symptoms In Patients Receiving Acetylsalicylic Acid/NSAIDs - NSAIDs Wave 2

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • The nature of upper GI symptoms (Dyspepsia and GERD) experienced by patients receiving acetylsalicylic acid and / or NSAIDS treatment [ Time Frame: single visit / once ]
  • 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 ]

Estimated Enrollment: 850
Study Start Date: March 2008
Study Completion Date: December 2008
Groups/Cohorts
1
Primary care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691743

Locations
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, Greece
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Rokkas Theodoros, MD Errikos Ntinan Hospital, Athens, Greece
  More Information

No publications provided

Responsible Party: Pontikis Panagiotis, MD, Medical Department Director, AstraZeneca Greece
ClinicalTrials.gov Identifier: NCT00691743     History of Changes
Other Study ID Numbers: NIS-GGR-DUM-2008/1
Study First Received: June 3, 2008
Last Updated: January 9, 2009
Health Authority: Greece: National Organization of Medicines

Keywords provided by AstraZeneca:
Upper GI Symptoms
GERD
NSAIDs

Additional relevant MeSH terms:
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014