Osteoarthritis | OASIS: Osteoarthritis Sensitivity Integration Study
Osteoarthritis research study
What is the primary objective of this 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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:Phenotype assessmentQuantitative sensory testing and patient reported outcome measures used to assess patient pain phenotype
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
DuloxetinePhenotype assessment prior to and after treatement with duloxetine 20-30 mg oral daily for eight weeks.
DiclofenacPhenotype assessment prior to and after treatment with topical diclofenac four times daily
Start Date: September 2011
Completed Date: July 2015
Primary Outcome: Pain
Study sponsors, principal investigator, and references
Principal Investigator: Kristine Phillips, MD, PhD
Lead Sponsor: University of Michigan