OASIS: Osteoarthritis Sensitivity Integration Study
- Conditions
- OsteoarthritisChronic Pain
- Registration Number
- NCT01377038
- Lead Sponsor
- University of Michigan
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Pain One month
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of Michigan🇺🇸Ann Arbor, Michigan, United States