Effectiveness Of Single Doses Of Ibuprofen In Patients With Osteoarthritis Of The Knee

A Double-Blind, Randomised, Placebo-Controlled, Cross-Over Pilot Study to Investigate the Efficacy of Ibuprofen in Patients With Osteoarthritis of the Knee Following Administration of a Single Dose

To demonstrate that new drugs work, many complex multidose studies are often required. The intent of this study is to use Ibuprofen as an example of a marketed pain relief drug to validate a simpler single dose model for future assessment of new pain drugs.

Inclusion criteria:

• Subjects diagnosed with primary Osteoarthritis of the knee.
• Have at least 3 months in symptom duration prior to screening visit.
• Regular user of a prescribed non-steroidal anti-inflammatory drug (NSAID) or selective cyclo-oxygenase II (COX2) inhibitor for management of knee pain.
• Pain walking on flat surface within specific interval prior to study start.

Exclusion criteria:

• History of hypersensitivity to NSAIDS.
• Allergy to Ibuprofen.
• Use of assistive devices other than a cane or knee brace.
• History of specified diseases/illnesses.
• Abnormal blood tests pre-study.