A double blind, placebo-controlled evaluation of dose realted safety and efficacy of epicutaneously applied IDEA-033 for 3 months treatment of osteoarthritis of the knee

INTERVENTION: Pharmaceutical Form: Pharmaceutical form of the placebo: Gel Route of administration of the placebo: Cutaneous use CONDITION: Osteoarthritis of the knee joint PRIMARY OUTCOME: Main Objective: To identify the dose(s) of IDEA‐033 that will provide a mimumum clinically meaningful effect for the treatment of signs and symptoms associated with osteoarthritis of the knee Primary end point(s): Change from baseline at Week 12 (or end of study measurements) on the Visual Analogue Scale version of the entire WOMAC Pain subscale; Patient global assessment of response to therapy measured on a 5 point Likert Scale at Week 12 (or end of study measurements); Change from baseline at Week 12 (or end of study measurements) on the Visual Analogue Scale of the entire WOMAC Function Secondary Objective: Comparissons of safety and efficacy of three doses of IDEA‐033 to placebo.; ; This study will also determine if there is an increase in the therapeutic effect with increasing dose of IDEA‐033 INCLUSION CRITERIA: Informed consent Age 18‐75 Clinical diagnosis of osteoarthritis (OA) in at least one knee for a mimumum of 6 months Eligible subjects must have used an oral or rectal NSAID on at least three days per week during the three months before screening or on at least 25 of the 30 days before screening, but be dissatisfied with the current NSAID treatment. At baseline, subjects must have a WOMAC Pain subscale greater than or equal to 40mm, and at least 15mm greater than at the screeningvisit in the index knee Radiographic evidence of OA, as specified in the protocol ACR functional class I, II or III Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range