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 [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2014 (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.
|Contact: Virginia Leone, MAfirstname.lastname@example.org|
|Contact: Craig Urwinemail@example.com|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Virginia Leone firstname.lastname@example.org|
|Contact: Craig Urwin email@example.com|
|Principal Investigator: Kristine Phillips, MD, PhD|
|Principal Investigator:||Kristine Phillips, MD, PhD||University of Michigan|