Back to resultsA 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
Primary Purpose
Acute Pain
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
K-285
Menthol
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility Criteria
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.
Sites / Locations
- Lotus Clinical Research, LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment Arm A
Treatment Arm B
Arm Description
K-285
Menthol
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
SPID 0-24 for study leg at rest
Using a 0-100 point eVAS scale
SPID 0-12 for study leg while standing and at rest
Using a 0-100 point eVAS scale.
SPID 0-48 for study leg while standing and at rest
Using a 0-100 point eVAS scale
SPID 0-72 for study leg while standing and at rest
Using a 0-100 point eVAS scale
Full Information
NCT ID
NCT04484428
First Posted
July 20, 2020
Last Updated
March 11, 2022
Sponsor
Kowa Research Institute, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04484428
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Internal business decision
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
March 19, 2021 (Actual)
Study Completion Date
March 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Research Institute, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm A
Arm Type
Experimental
Arm Description
K-285
Arm Title
Treatment Arm B
Arm Type
Active Comparator
Arm Description
Menthol
Intervention Type
Drug
Intervention Name(s)
K-285
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Menthol
Intervention Description
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.
Primary Outcome Measure Information:
Title
The sum of pain intensity difference (SPID) between 0 to 24 hours (SPID 0-24) for study leg while standing
Description
Using a 0-100 point electronic visual analog scale (eVAS)
Time Frame
0 to 24 hours after the first gel application
Secondary Outcome Measure Information:
Title
SPID 0-24 for study leg at rest
Description
Using a 0-100 point eVAS scale
Time Frame
0 to 24 hours after the first gel application
Title
SPID 0-12 for study leg while standing and at rest
Description
Using a 0-100 point eVAS scale.
Time Frame
0 to 12 hours after the first gel application
Title
SPID 0-48 for study leg while standing and at rest
Description
Using a 0-100 point eVAS scale
Time Frame
0 to 48 hours after the first gel application
Title
SPID 0-72 for study leg while standing and at rest
Description
Using a 0-100 point eVAS scale
Time Frame
0 to 72 hours after the first gel application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Lotus Clinical Research, LLC
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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