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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

NCT04484428 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2024-12-27

Study results available
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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.

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.

Sponsors & Collaborators

  • Kowa Research Institute, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-15
Primary Completion
2021-03-19
Completion
2021-03-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04484428 on ClinicalTrials.gov