Delayed Onset Muscle Soreness, DOMS Clinical Trial
Official title:
Double-blind, Randomized, Placebo-controlled, Single-center, Exploratory Clinical Trial to Investigate Safety and Efficacy of COMBOPROFEN for Treatment of Muscular Pain Associated With DOMS.
The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of Comboprofen (Ibuprofen + Magnesium + Vitamin C) compared to placebo, Ibuprofen, Magnesium and Vitamin C monotherapies in the treatment of Delayed Onset Muscle Soreness (DOMS).
The study is designed as a proof of concept, single-center, randomized, double-blind, placebo
controlled study to assess the safety and efficacy of Comboprofen (Ibuprofen + Magnesium +
Vitamin C) compared to placebo, Ibuprofen, Magnesium and Vitamin C monotherapies in the
treatment of Delayed Onset Muscle Soreness (DOMS).
Healthy volunteers will be recruited to undergo a controlled exercise test designed to induce
DOMS in lower limbs. Subjets reporting sufficient pain intensity while walking in an 11-point
Numerical Rating Scale (NRS) 24h or 48 h after exercise will be randomized to receive
treatment with Comboprofen, placebo, ibuprofen, magnesium or vitamin c three times a day
(TID) for 3 days.
Once a subject is randomized the duration of participation will be 7 days. Subjects will be
housed in the clinic for the first 24 hours of dosing. Pain intensity while standing up and
sitting down and while walking will be assessed throughout the study using an 11-point (0-10)
Numeric Rating Scale (NRS). Maximal isometric force, muscle damage and inflammatory markers
will be also assessed throughout the study.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02597634 -
Study of SST-0225 Topical Ibuprofen Cream in the Treatment of Delayed Onset Muscle Soreness (DOMS)
|
Phase 3 |