title: A multicentre, randomized, placebo- and active-controlled trial comparing the efficacy and safety of topical ketoprofen in Transfersome gel (IDEA-033) with ketoprofen-free vehicle (TDT 064) and oral celecoxib for knee pain associated with osteoarthritis.
abstract: OBJECTIVE
  To assess the efficacy and safety of 12-week treatment with ketoprofen in ultradeformable phospholipid vesicles in patients with OA knee pain and to compare the efficacy with that of ketoprofen-free vehicle and celecoxib. METHODS; A multicentre, double-blind controlled study in which patients with knee OA and moderate pain were randomized to one of the six arms: topical ketoprofen 50 or 100 mg in ultradeformable vesicles (IDEA-033), 2.2 or 4.4 g ketoprofen-free vehicle (TDT 064), oral celecoxib 100 mg or matching oral placebo, all bd. The primary outcome was change from baseline in the WOMAC pain subscale at week 12.
  
  
  RESULTS
  A total of 1395 patients received treatment. Baseline mean WOMAC pain scores ranged from 4.7 to 4.8 across groups. The mean reduction in WOMAC pain score at week 12 was -1.9 (-40.8%) for ketoprofen 50 mg, -1.9 (-40.9%) for ketoprofen 100 mg, -1.9 (-39.8%) for 2.2 g TDT 064, -1.8 (-37.8%) for 4.4 g TDT 064, -1.9 (-40.4%) for celecoxib and -1.4 (-29.3%) for oral placebo. IDEA-033 was not statistically superior to TDT 064. All topical treatments were statistically superior to oral placebo and non-inferior to celecoxib. The most frequent types of treatment-related adverse events reported were gastrointestinal for oral (15.9% for celecoxib) and dermal for topical applications (12.2% for ketoprofen 100 mg).
  
  
  CONCLUSIONS
  IDEA-033 was not superior to ketoprofen-free vehicle, but both formulations were superior to oral placebo and non-inferior to celecoxib in reducing OA knee pain.
  
  
  BACKGROUND
  ClinicalTrials.gov, http://clinicaltrials.gov/, NCT00716547.
authors.affiliation: University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK. p.conaghan@leeds.ac.uk
authors.forename: Philip G
authors.initials: PG
authors.lastname: Conaghan
authors.forename: John
authors.initials: J
authors.lastname: Dickson
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Bolten
authors.forename: Gregor
authors.initials: G
authors.lastname: Cevc
authors.forename: Matthias
authors.initials: M
authors.lastname: Rother
mesh_terms: D000284:Administration, Oral; D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D000068579:Celecoxib; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004337:Drug Carriers / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005782:Gels; D006801:Humans; D007660:Ketoprofen / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy* / Q000503:physiopathology; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement; D011720:Pyrazoles / Q000008:administration & dosage* / Q000009:adverse effects; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D004337:Drug Carriers; D005782:Gels; D011720:Pyrazoles; D013449:Sulfonamides; D007660:Ketoprofen; D000068579:Celecoxib
keywords: IDEA-033; TDT 064; Transfersome; ketoprofen; osteoarthritis; topical therapy