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

PHASE2TerminatedINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

August 15, 2020

Primary Completion Date

March 19, 2021

Study Completion Date

March 19, 2021

Conditions
Acute Pain
Interventions
DRUG

K-285

88 subjects are to be assigned to 1 week dosing, four times a day (QID) (Period 1), and 32 are to be assigned to 3 weeks dosing (Period 1 and Period 2) with 16 subjects each in the two times a day (BID) and QID dosing regimens.

DRUG

Menthol

88 subjects are to be assigned to 1 week dosing, four times a day (QID) (Period 1), and 32 are to be assigned to 3 weeks dosing (Period 1 and Period 2) with 16 subjects each in the two times a day (BID) and QID dosing regimens.

Trial Locations (1)

91105

Lotus Clinical Research, LLC, Pasadena

Sponsors
All Listed Sponsors
lead

Kowa Research Institute, Inc.

INDUSTRY

NCT04484428 - 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 | Biotech Hunter | Biotech Hunter