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.

Keywords:

• exercise
• IDEA-033
• oral NSAID
• muscle soreness
• TDT 064
• joint pain

Acknowledgements

We would like to thank all volunteers and investigators involved in the study.

Additional information

Funding

This study was sponsored by IDEA AG, Munich, Germany. Editorial assistance with the preparation of the manuscript was provided by Bollin Strategies Ltd., UK, and was funded by Pro Bono Bio Entrepreneur Ltd., UK. Dr M. Rother and Dr I. Rother were employees of IDEA AG at the time when the study was conducted and are paid consultants of Pro Bono Bio Entrepreneur Ltd. Dr E.J. Seidel and Dr K. Regenspurger received investigator grants from the sponsor of the study and Dr E.J. Seidel has received consultancy payments from Pro Bono Bio Entrepreneur Ltd.