Brain Morphometry in OA Patients Treated With Duloxetine

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: Eli Lilly and Company
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Currently taking MAO inhibitors or any centrally acting drug for analgesia

• Narrow angle glaucoma

• Uncontrolled hypertension

• 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