The risk of oral NSAID including @entity2247 inhibitors to cause @entity65 adverse events related to systemic drug exposure could be reduced by local application. But only few long-term studies have been published to show safety and efficacy for long-term use of topical NSAID s. Diractin (formerly IDEA-033) is a viscous, aqueous formulation for epicutaneous application of @entity7988 based on ultra-deformable, self-regulating carrier (Transfersome). This multiple-dose, open label study with treatment periods up to 18 months included 402 @entity1 with joint @entity158 , @entity4512 , @entity2693 or soft tissue @entity32 (age of 61.4+/-11.5 years). Most of the @entity1 suffered from @entity571 ( @entity571 ) of the knee (68.9%). Diractin was applied epicutaneously up to twice daily with a maximum dose of 220 mg @entity7988 per a maximum of 2 application sites. The mean @entity158 score at baseline was 5.4+/-.4 on a 10 point categorical scale. During the study the @entity158 score progressively improved up to week 36 (3.5+/-1.9) without a substantial further change during the rest of observation period of up to 18 months. The reduction of @entity158 scores between week 0 (baseline) and at all later visits was statistically significant (P<0.0001). @entity1 also reported an improvement of quality of life on the EUROQoL. The majority of treatment related adverse events were skin and @entity3145 with the highest frequency reported for erythema (16.7%) and @entity111 (2.0%). Systemic @entity7988 exposure remained low throughout the study period with plasma concentrations of less than 1% of what was reported for a single, standard oral dose of 200 mg @entity7988 . There were no occurrences of treatment related serious adverse events and no remarkable changes in laboratory values or vital signs. In summary, Diractin provided adequate @entity158 relief with a good safety and tolerability profile when used for up to 18 months (72 weeks).

A multiple-dose, open-label, safety, compliance, and usage evaluation study of epicutaneously applied Diractin ( @entity7988 in Transfersome) in joint/ XXXX or soft tissue @entity32 .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity7988 :: ('MESH:D007660', 'Chemical') :: ['ketoprofen'] @entity4512 :: ('MESH:D059352', 'Disease') :: ['musculoskeletal pain'] @entity32 :: ('MESH:D007249', 'Disease') :: ['inflammation'] @entity571 :: ('MESH:D010003', 'Disease') :: ['osteoarthritis', 'OA'] @entity3145 :: ('MESH:D017695', 'Disease') :: ['subcutaneous tissue disorders'] @entity111 :: ('MESH:D011537', 'Disease') :: ['pruritus'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain'] @entity2247 :: ('4513', 'Gene') :: ['Cox-2'] @entity65 :: ('MESH:D002318', 'Disease') :: ['gastrointestinal, renal or cardiovascular'] @entity2693 :: ('MESH:C566112', 'Disease') :: ['stiffness']
@entity4512 :: (MESH:D059352,Disease) :: ['musculoskeletal pain']
