A Study to Evaluate the Efficacy and Safety of K-285 Compared With Menthol Gel for the Treatment … (NCT04484428) | Clinical Trial Compass
TerminatedPhase 2
A Study to Evaluate the Efficacy and Safety of K-285 Compared With Menthol Gel for the Treatment of Delayed Onset Muscle Soreness (DOMS) in the Lower Extremity
Stopped: Internal business decision
United States126 participantsStarted 2020-08-15
Plain-language summary
The purpose of this study to evaluate the efficacy and safety of K-285 compared with menthol gel for the treatment of delayed onset muscle soreness (DOMS) in the lower extremity.
Who can participate
Age range18 Years – 35 Years
SexALL
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Inclusion Criteria:
* Subject must provide informed consent before any study-specific evaluation is performed.
* Subject is male and female aged 18 to 35 years, inclusive.
* Subject has a body mass index of 18 to 32 kg/m2, inclusive.
* Subject meets all inclusion criteria outlined in the Clinical Study Protocol.
Exclusion Criteria:
* Subject has a job (e.g., movers, construction workers) that requires regular lifting or involvement of the lower extremities.
* Subject has restless leg syndrome, a chronic pain condition, a history of intermittent claudication, or has taken any medication (e.g., analgesic medication, sleep medication, muscle relaxant, anticonvulsant, or antidepressant) in the last 6 months to treat a chronic pain condition, or has another painful physical condition in a lower extremity that, in the opinion of the investigator, may confound study assessments.
* Subject has received oral or topical analgesic medications within 14 days before the Screening Visit.
* Subject meet any other exclusion criteria outlined in the Clinical Study Protocol.
What they're measuring
1
Sum of Pain Intensity Difference Between 0 to 24 Hours (SPID0-24) for Study Leg While Standing