Duloxetine in Osteoarthritis (OA) Pain

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

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