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AB0990 A double-blind, randomised, placebo-controlled trial to evaluate the safety and efficacy of epicutaneously applied ketoprofen in transfersome gel for the treatment of pain associated with osteoarthritis (OA) of the knee
  1. M. Rother1,
  2. R. Lipetz2,
  3. S. Dunmyer3
  1. 1IMR Partner GmbH, Munich, Germany
  2. 2Encompass Clinical Research, Spring Valley
  3. 3Pharmacotherapy Research Associates, Inc., Zanesville, United States

Abstract

Background IDEA 033 is an epicutaneously applied formulation of ketoprofen in Transfersome – aqueous dispersion of ultra-deformable carriers – for the treatment of pain in OA, which potentially minimises systemic adverse events (AEs) associated with non-steroidal anti-inflammatory drugs.

Objectives To evaluate the efficacy and safety of 100mg ketoprofen in Transfersome gel (IDEA 033) compared with a matching epicutaneous placebo (Transfersome gel without ketoprofen; TDT 064) in patients with mild/moderate pain associated with OA of the knee.

Methods A multicentre, randomised, double-blind, placebo-controlled trial in patients with radiologically confirmed OA of the knee who met Functional Class I–III OA and ACR clinical classification criteria, had mild/moderate pain at baseline [defined by score ≥4 for question 1 of WOMAC OA Index (ver 3.1) and total mean WOMAC pain score <7]. Patients received 12 weeks of therapy twice daily with 100mg ketoprofen in Transfersome (IDEA 033) or matching epicutaneous placebo (TDT 064). Pain and function were assessed at baseline and weeks 2, 6, 9 and 12 using the WOMAC. Patient global assessment of response to therapy was measured on a 5-point Likert scale at week 12. Vital signs, AEs and laboratory parameters were assessed.

Results The intent-to-treat and safety populations consisted of 555 patients. Median WOMAC pain subscale scores at baseline were lower than expected (Table). Throughout the study, both groups reported constant pain decreases, while improvements in physical function were constant and comparable in both groups (Table). Marginal inferiority was demonstrated for IDEA 033 versus TDT 064 for pain and function (Mann–Whitney estimator 0.4505 and 0.4570, respectively). The incidence of ≥1 AE was comparable in both groups (Table). Serious AEs were reported by 3 patients receiving IDEA 033 (1 was possibly related to treatment) and 4 patients receiving TDT 064 (none were related to treatment).

Table 1. Efficacy and safety outcomes

Conclusions Twelve weeks of therapy with epicutaneously applied ketoprofen (100mg) in Transfersome (IDEA 033) was not statistically superior to epicutaneous placebo (Transfersome without ketoprofen; TDT 064), possibly owing to low baseline pain severity in both groups and substantial changes from baseline reported for TDT 064, thus preventing demonstration of an additional benefit for ketoprofen in Transfersome. Both treatments were well tolerated. Further investigation of the beneficial effect of the epicutaneous placebo (TDT 064) is ongoing.

Disclosure of Interest M. Rother Shareholder of: IDEA AG (sponsor of the trial), Employee of: IDEA AG (sponsor of the trial) at the time of trial conduct, R. Lipetz: None Declared, S. Dunmyer: None Declared

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