Status:
TERMINATED
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
Lead Sponsor:
Kowa Research Institute, Inc.
Conditions:
Acute Pain
Eligibility:
All Genders
18-35 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2021
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04484428
Start Date
August 15 2020
End Date
March 19 2021
Last Update
December 27 2024
Active Locations (1)
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1
Lotus Clinical Research, LLC
Pasadena, California, United States, 91105