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

• Sponsor: Kowa Research Institute, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04484428
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.1
• Patients Per Site Per Month: 17.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Pain	Drug: K-285; Drug: Menthol	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 15, 2020
• Actual Primary Completion Date: Mar 19, 2021
• Actual Study Completion Date: Mar 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Arm A K-285	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.
Active Comparator: Treatment Arm B Menthol	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.

Outcome Measures

Primary Outcome Measures

1. The sum of pain intensity difference (SPID) between 0 to 24 hours (SPID 0-24) for study leg while standing [0 to 24 hours after the first gel application]

   Using a 0-100 point electronic visual analog scale (eVAS)

Secondary Outcome Measures

1. SPID 0-24 for study leg at rest [0 to 24 hours after the first gel application]

   Using a 0-100 point eVAS scale

2. SPID 0-12 for study leg while standing and at rest [0 to 12 hours after the first gel application]

   Using a 0-100 point eVAS scale.

3. SPID 0-48 for study leg while standing and at rest [0 to 48 hours after the first gel application]

   Using a 0-100 point eVAS scale

4. SPID 0-72 for study leg while standing and at rest [0 to 72 hours after the first gel application]

   Using a 0-100 point eVAS scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lotus Clinical Research, LLC	Pasadena	California	United States	91105

Sponsors and Collaborators

• Kowa Research Institute, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kowa Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT04484428
• Other Study ID Numbers: K-285-201
• First Posted: Jul 23, 2020
• Last Update Posted: Mar 16, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Myalgia; Acute Pain; Menthol

Study Results

No Results Posted as of Mar 16, 2022