Assess the Blood-Oxygen-Level-Dependent (BOLD) Signal Changes in the Brain by Paracetamol as Measured by Functional Magnetic Resonance Imaging (fMRI) in Subjects With Osteoarthritis (OA)

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Blood-Oxygen-Level-Dependent (BOLD) responses to painful mechanical stimulation of the OA knee following treatment with four consecutive doses (at 8 hour intervals) on giving sustained released paracetamol treatment or placebo will be compared. The fMRI and pain assessments will occur approximately 2-5 hours after taking the final dose.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• Diagnosis of osteoarthritis of at least one knee for 3 months

• Male or female at least 45 years of age

• Score a minimum of 4 out of 10 on the numerical pain rating and a maximum of 8 at screening

Exclusion Criteria:

• If female, is pregnant, lactating, or breast feeding

• Has secondary cause of knee arthritis

• Lower extremity surgery in the last 6 months

• Prior injury in the last twelve months to the index knee

• Used any analgesics (NSAIDs, COX2 inhibitor, etc) within 5 half lives of study start

• Recently used oral or injected glucocorticoids