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

• Status: Terminated
• Trial end date: 2021-03-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kowa Research Institute, Inc.
• Treatments: Menthol

Criteria

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.