Delayed Onset Muscle Soreness (DOMS) is an acute pain state that arises 24-48 hours after unaccustomed or eccentric exercise. As an analgesic model, it is well suited for testing topical over-the-counter or prescription analgesics.
Lotus Clinical Research has performed several large-scale studies (operating as both a site and the CRO) in the DOMS model. Dr. Singla has also published a methodological review article in PAIN concerning experimental best practices for DOMS.
Average enrollment is 40 subjects per month at the Lotus Clinical Research site. Screen failure rates are similar to a healthy volunteer population, but may be slightly higher due to activity restrictions specific to recruitment of the DOMS population
Phase | Sponsor | Enrolled by Lotus | Total Study N | Clinical Trials.gov Identifier No |
---|---|---|---|---|
4 | Lotus | 24 | 24 | NCT02087748 |
3 | Novartis | 102 | 102 | NCT02271854 |
2 | Aponia | 144 | 144 | NCT02324985 |