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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00699725 |
Prospective multicentric study to evaluate the compliance of gastroprotective treatment in NSAID patients at risk of GI complications. Secondary objectives: To identify the factors associated to treatment compliance (both NSAID and PPI), to evaluate the relationship between compliance and NSAID-associated GI events
Condition |
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Compliance Gastroprotector Therapy Risk Factors |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Compliance of Gastroprotection Treatment in the Prevention of Gastrointestinal Risk in Non-Steroidal Anti-Inflammatory Drug (NSAID) Using Patients |
Estimated Enrollment: | 2000 |
Study Start Date: | May 2008 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
NSAID patients with risk factors treated with gastroprotective drugs
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients attending secondary care clinics who are prescribed NSAID and gastroprotection for at least 15 days following standard clinical practice.
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Javier Zapardiel | AstraZeneca Spain Medical Dept |
Responsible Party: | AstraZeneca Pharmaceuticals ( Mercedes Muñoz, PhD, Local MC GI Therapeutic Area Manager ) |
Study ID Numbers: | NIS-GES-DUM-2008/2 |
Study First Received: | June 17, 2008 |
Last Updated: | February 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00699725 History of Changes |
Health Authority: | Spain: Ethics Committee |
Compliance gastroprotector therapy NSAID risk factors |
Anti-Inflammatory Agents Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal |
Peripheral Nervous System Agents Analgesics Antirheumatic Agents |
Anti-Inflammatory Agents Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs |
Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Pharmacologic Actions |