The Efficacy of Diclofenac Gel for Breakthrough Pain and the Neuropathic Components of Pain in Knee Osteoarthritis

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this proposed study is to conduct a trial with knee osteoarthritis (OA) patients using the diclofenac gel.

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

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: Endo Pharmaceuticals
• Treatments: Diclofenac

Criteria

Inclusion Criteria:

• Ages 20-75

• Unilateral or bilateral knee osteoarthritis (OA), confirmed radiographically.

• Patients taking oral non-steroidal anti-inflammatory drugs (NSAIDs) in the amount and schedule prior to the breakthrough period will be permitted.

Exclusion Criteria:

• Patients with clinical history of anterior cruciate ligament (ACL) involvement.

• Patients on tricyclic antidepressants or anticonvulsants (neuropathic medications)

• History of ulcers or gastrointestinal (GI) bleeding

• Coagulation disorders

• Hypersensitivity to Aspirin or NSAIDS

• Congestive Heart Failure and Edema

• Advanced renal disease

• Aspirin triad

• Pregnant women