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. Issue 1 (2nd January 2016)

• Record Type: Journal Article
• Authors: Seidel, Egbert J.; Rother, Matthias; Regenspurger, Katja; Rother, Ilka
• Is Part Of: Journal of sports sciences. Volume 34:Issue 1(2016)
• Page Start: 88
• Page End: 95
• Publication Date: 2016-01-02
• Subjects: exercise -- IDEA-033 -- oral NSAID -- muscle soreness -- TDT 064 -- joint pain; Sports -- Periodicals; Sports -- Physiological aspects -- Periodicals; Sports -- Psychological aspects -- Periodicals; 612.044
• DOI: 10.1080/02640414.2015.1035667
• Languages: English
• ISSNs: 0264-0414

Abstract

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.