Osteoarthritis Topical Treatment

A Pilot Study to Compare the Efficacy and Safety of a Novel 10% Ibuprofen Formulation Versus Placebo Alone Applied to the Knee in Patients With Painful Osteoarthritis of the Knee

This is a phase 2a clinical trial performed to evaluate the efficacy of a topical treatment of ibuprofen compared to the use of a placebo topical treatment.

A multi-center, double-blinded, randomized placebo controlled study. Study length: 14 days Dosing twice daily (b.i.d.)

Main Inclusion Criteria:

• Male or female patients aged at least 40 years.
• Primary osteoarthritis in a single knee joint, grade II/III based on the Kellgren and Lawrence classification system.
• Radiographic evidence consistent with osteoarthritis carried out within 6 months before screening.
• pain is currently not adequately controlled with a simple analgesic or an NSAID OR would necessitate treatment, but is not yet treated.

Main Exclusion Criteria:

• Concomitant presence of another type of continuous pain that is more severe in intensity in comparison with the osteoarthritis target joint pain
• Osteoarthritis causing significant pain in any joint other than the identified knee, or contralateral knee (≥ 20 mm pain) as confirmed by a separate VAS at visit 1 for any other painful joint concerned.
• Female patients who are pregnant or breast-feeding.