OASIS: Osteoarthritis Sensitivity Integration Study
This trial is active, not recruiting.
|Conditions||osteoarthritis, chronic pain|
|Sponsor||University of Michigan|
|Collaborator||National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|
|Start date||September 2011|
|End date||November 2015|
|Trial size||70 participants|
|Trial identifier||NCT01377038, 1K23AR060241-01, 2011 HUM00044644, UL1RR024986|
The primary objective of this study is to evaluate the relative efficacy of a centrally-acting analgesic (duloxetine) versus a peripherally acting analgesic (topical diclofenac) for pain and associated symptom management in knee osteoarthritis. Secondary objectives include the determination of which self-report and experimental pain measures best differentiate those who respond better to duloxetine than diclofenac.
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
time frame: One month
Male or female participants at least 50 years old.
Inclusion Criteria: - Diagnosed with knee osteoarthritis as defined by American College of Rheumatology (ACR) criteria - Males and females age greater than 50 years at time of screening Exclusion Criteria: - History of chronic kidney disease or moderate to severe hepatic impairment - History of anemia - Allergy or intolerance of drug intervention - Inability to participate in outcome measures
|Official title||Central Pain Mechanisms in Osteoarthritis: A Randomized, Double-blind, Crossover Study to Evaluate the Effectiveness of Topical Diclofenac Versus Duloxetine for Chronic Osteoarthritis Pain|
|Principal investigator||Kristine Phillips, MD, PhD|
|Description||This is a randomized, blinded, crossover, controlled study design comparing duloxetine and topical diclofenac for osteoarthritis pain. The study cohort will be individuals who have a confirmed diagnosis of knee osteoarthritis. Subjects will be randomized only after all entry criteria have been met. These individuals will be evaluated at baseline, and then followed longitudinally following enrollment.|
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