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

Acute Pain Clinical Trial

Official title:

A Phase II, Randomized, Double-blind, Active Comparator, Parallel Group 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04484428
• Other study ID #: K-285-201
• Status: Terminated
• Phase: Phase 2
• Start date: August 15, 2020
• Est. completion date: March 19, 2021

Study information

• Verified date: March 2022
• Source: Kowa Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 126
• Est. completion date: March 19, 2021
• Est. primary completion date: March 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Myalgia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Lotus Clinical Research, LLC	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sum of pain intensity difference (SPID) between 0 to 24 hours (SPID 0-24) for study leg while standing	Using a 0-100 point electronic visual analog scale (eVAS)	0 to 24 hours after the first gel application
Secondary	SPID 0-24 for study leg at rest	Using a 0-100 point eVAS scale	0 to 24 hours after the first gel application
Secondary	SPID 0-12 for study leg while standing and at rest	Using a 0-100 point eVAS scale.	0 to 12 hours after the first gel application
Secondary	SPID 0-48 for study leg while standing and at rest	Using a 0-100 point eVAS scale	0 to 48 hours after the first gel application
Secondary	SPID 0-72 for study leg while standing and at rest	Using a 0-100 point eVAS scale	0 to 72 hours after the first gel application