OASIS: Osteoarthritis Sensitivity Integration Study
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Pain [ Time Frame: One month ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377038
|Contact: Kathy Scott, RN||734-615-6910|
|Contact: Ryan Scott||734-998-7110|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Kathy Scott|
|Principal Investigator: Kristine Phillips, MD, PhD|
|Principal Investigator:||Kristine Phillips, MD, PhD||University of Michigan|