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 range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sum of Pain Intensity Difference Between 0 to 24 Hours (SPID0-24) for Study Leg While Standing

Timeframe: Baseline to 24 Hours

Trial details

NCT IDNCT04484428

SponsorKowa Research Institute, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-03-19

Results submitted2024-03-11

View on ClinicalTrials.gov More Acute Pain trials

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.