This is a two week,single-blind study evaluating pain response and changes in brain imaging
upon treatment with placebo in people with knee OA.
Drug: Placebo Oral Tablet
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Locations near you
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Full eligibility criteria for NCT02903238
Ages eligible for Study
40 Years to 85 Years
Genders eligible for Study
Accepts Healthy Volunteers
Age: 40-85 years
ACR criteria for OA including Kellgren-Lawrence radiographic OA grades II-IV
VAS pain score >5/10 within 48 hrs of the phone screen and visit 1 (Screening)
Knee OA for a minimum of 12 months
Need for daily pain medication to manage symptoms of OA
Currently taking MAO inhibitors or any centrally acting drug for analgesia
Narrow angle glaucoma
Co-existing inflammatory arthritis, fibromyalgia or other chronic pain state
If a female, pregnant, trying to become pregnant, or lactating
Major depressive disorder
Substantial alcohol use or history of significant liver disease
Diabetes, type 1 or type 2
Condition in which the Investigator believes would interfere with the subject's ability to comply with study instructions, or might confound the interpretation of the study results or put the subject at undue risk
Standard MRI safety exclusions
All locations for NCT02903238
United States (1)
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
View full eligibility
Tris trial is registered with FDA with number: NCT02903238. The sponsor of the trial is Northwestern University and it is looking for 21 volunteers for the current phase.
Official trial title: Brain Morphometric Study in Knee Osteoarthritis Patients Treated With Duloxetine
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