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Sponsors and Collaborators: |
Pfizer King's College London St Thomas' Hospital, London |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00830050 |
The study hypothesis is that the relief of pain in patients with osteoarthritis in the hand can be detected by a form of brain scanning that detects which parts of the brain are activated when pain is felt.
Condition | Intervention | Phase |
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Osteoarthritis |
Drug: Naproxen Drug: Placebo |
Phase 0 |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacodynamics Study |
Official Title: | A Study To Determine The Ability Of FMRI To Detect And Quantify The Effect Of Naproxen On Osteoarthritis Of The Hand |
Estimated Enrollment: | 24 |
Study Start Date: | August 2009 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Naproxen
500 mg BID 7 days
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Arm 2: Placebo Comparator |
Drug: Placebo
BID 7 days
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Ages Eligible for Study: | 50 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Centre for Neuroimaging Sciences | +44 (7919) 3047 | matthew.howard@iop.kcl.ac.uk |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A9001399 |
Study First Received: | January 26, 2009 |
Last Updated: | August 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00830050 History of Changes |
Health Authority: | United Kingdom: Research Ethics Committee |
fMRI
functional magnetic resonance imaging
Pain |
Anti-Inflammatory Agents Naproxen Osteoarthritis Joint Diseases Cyclooxygenase Inhibitors Pain Rheumatic Diseases |
Musculoskeletal Diseases Analgesics, Non-Narcotic Arthritis Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents |
Anti-Inflammatory Agents Naproxen Molecular Mechanisms of Pharmacological Action Osteoarthritis Joint Diseases Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Rheumatic Diseases Gout Suppressants Pharmacologic Actions |
Musculoskeletal Diseases Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Arthritis Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |