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 early · Phase 2

Conditions studied: Acute Pain

In brief

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.

Key facts

Study ID

NCT04484428

Run by

Kowa Research Institute, Inc.

People needed

126

Starts

2020-08-15

Expected to finish

2021-03-19

Last updated by the study team

2024-12-27

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Lotus Clinical Research, LLC — Pasadena, California, United States

Full record on ClinicalTrials.gov

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