- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
March 11, 2022 updated by: Kowa Research Institute, Inc.
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
126
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Pasadena, California, United States, 91105
- Lotus Clinical Research, LLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Arm A
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The sum of pain intensity difference (SPID) between 0 to 24 hours (SPID 0-24) for study leg while standing
Time Frame: 0 to 24 hours after the first gel application
|
Using a 0-100 point electronic visual analog scale (eVAS)
|
0 to 24 hours after the first gel application
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SPID 0-24 for study leg at rest
Time Frame: 0 to 24 hours after the first gel application
|
Using a 0-100 point eVAS scale
|
0 to 24 hours after the first gel application
|
SPID 0-12 for study leg while standing and at rest
Time Frame: 0 to 12 hours after the first gel application
|
Using a 0-100 point eVAS scale.
|
0 to 12 hours after the first gel application
|
SPID 0-48 for study leg while standing and at rest
Time Frame: 0 to 48 hours after the first gel application
|
Using a 0-100 point eVAS scale
|
0 to 48 hours after the first gel application
|
SPID 0-72 for study leg while standing and at rest
Time Frame: 0 to 72 hours after the first gel application
|
Using a 0-100 point eVAS scale
|
0 to 72 hours after the first gel application
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2020
Primary Completion (Actual)
March 19, 2021
Study Completion (Actual)
March 19, 2021
Study Registration Dates
First Submitted
July 20, 2020
First Submitted That Met QC Criteria
July 20, 2020
First Posted (Actual)
July 23, 2020
Study Record Updates
Last Update Posted (Actual)
March 16, 2022
Last Update Submitted That Met QC Criteria
March 11, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K-285-201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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