Duloxetine in Osteoarthritis (OA) Pain

Completed · Phase 4 · Has a placebo group

Conditions studied: Osteoarthritis

In brief

This study aims to determine in people with knee Osteoarthritis (OA) if relief of pain after treatment with either duloxetine or placebo is associated with changes in brain anatomy.

Key facts

Study ID

NCT01558700

Run by

Northwestern University

People needed

40

Starts

2012-03-01

Expected to finish

2014-08-01

Last updated by the study team

2014-12-29

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age: 45-80 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

You may not qualify if…

• Currently taking MAO inhibitors or any centrally acting drug for analgesia, depression
• 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
• Use of MAO inhibitors, triptans, serotonin precursors (tryptophan)
• Use of potent CYP1A2 inhibitors, Thioridazine, and anti-depressants
• 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
• MRI safety necessitates the exclusion of subjects having one or more of the following:
• Metal fragments in the eye or face, or having worked previously in the metal industry
• Implantation of any electronic devices such as (but not limited to) cardiac pacemakers, cardiac, defibrillators, and cochlear implants or nerve stimulators.
• Surgery on the blood vessels of the brain
• Claustrophobia (fear of enclosed places)
• Piercings or tattoos
• More than 250 lbs in weight
• Obvious brain abnormalities

Where it is running

• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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