title: A randomised trial comparing the efficacy and safety of topical ketoprofen in Transfersome(®) gel (IDEA-033) with oral ketoprofen and drug-free ultra-deformable Sequessome™ vesicles (TDT 064) for the treatment of muscle soreness following exercise.
abstract: We compared the effectiveness of topical ketoprofen in Transfersome(®) gel (IDEA-033) with oral ketoprofen and drug-free Sequessome™ vesicles (FLEXISEQ(®) Sport; TDT 064) in reducing calf muscle soreness. One hundred and sixty eight healthy individuals with a pain score ≥ 3 (10-point scale) 12-16 h post-exercise (walking down stairs with an altitude of 300-400 m) were randomised to receive IDEA-033 plus oral placebo (two dose groups), oral ketoprofen plus TDT 064, or TDT 064 plus oral placebo. The primary endpoint was muscle soreness reduction from pre-dosing to Day 7. Higher pain scores were recorded with oral ketoprofen plus TDT 064 (mean ± s 462.4 ± 160.4) versus IDEA-033 plus oral placebo (434.7 ± 190.8; P = 0.2931) or TDT 064 plus oral placebo (376.2 ± 159.1; P = 0.0240) in the 7 days post-exercise. Recovery from muscle soreness was longer with oral ketoprofen plus TDT 064 (mean 91.0 ± 19.5 h) versus IDEA-033 plus placebo (mean 81.4 ± 22.9 h; P = 0.5964) or TDT 064 plus placebo (mean 78.9 ± 22.8 h; P = 0.0262). In conclusion, ultradeformable phospholipid vesicles ± ketoprofen did not retard recovery from muscle soreness. TDT 064 improves osteoarthritis-related pain and could be of interest as a treatment for joint pain during and post-exercise.
authors.affiliation: a Department of Physical and Rehabilitation Medicine, Sophien- and Hufeland-Clinic , Weimar , Germany.
authors.forename: Egbert J
authors.initials: EJ
authors.lastname: Seidel
authors.affiliation: b IMR Partner GmbH , Graefelfing , Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Rother
authors.affiliation: a Department of Physical and Rehabilitation Medicine, Sophien- and Hufeland-Clinic , Weimar , Germany.
authors.forename: Katja
authors.initials: K
authors.lastname: Regenspurger
authors.affiliation: b IMR Partner GmbH , Graefelfing , Germany.
authors.forename: Ilka
authors.initials: I
authors.lastname: Rother
mesh_terms: D000284:Administration, Oral; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D019540:Area Under Curve; D004311:Double-Blind Method; D015444:Exercise / Q000502:physiology*; D005260:Female; D005782:Gels; D006801:Humans; D007660:Ketoprofen / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D008297:Male; D008875:Middle Aged; D063806:Myalgia / Q000188:drug therapy* / Q000209:etiology; D014677:Pharmaceutical Vehicles / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D010743:Phospholipids / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D005782:Gels; D014677:Pharmaceutical Vehicles; D010743:Phospholipids; D007660:Ketoprofen
keywords: IDEA-033; TDT 064; exercise; joint pain; muscle soreness; oral NSAID