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

Kowa

Status and phase: Terminated; Phase 2

Conditions: Acute Pain

Treatments: Drug: Menthol; Drug: K-285

Study type: Interventional

Funder types: Industry

Identifiers

NCT04484428

K-285-201

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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126 participants in 2 patient groups

Treatment Arm A

Experimental group

Description:

K-285

Treatment:

Drug: K-285

Treatment Arm B

Active Comparator group

Description:

Menthol

Treatment:

Drug: Menthol