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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

NCT ID: NCT04484428

Last Updated: 2024-12-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-15

Study Completion Date

2021-03-19

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Treatment Arm A

K-285

Group Type EXPERIMENTAL

K-285

Intervention Type DRUG

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.

Treatment Arm B

Menthol

Group Type ACTIVE_COMPARATOR

Menthol

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kowa Research Institute, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lotus Clinical Research, LLC

Pasadena, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol: Clinical Study Protocol Ver 1.0

View Document

Document Type: Study Protocol: Clinical Study Protocol Ver 2.0

View Document

Document Type: Statistical Analysis Plan: SAP Interim Analysis

View Document

Document Type: Statistical Analysis Plan: SAP Final

View Document

Other Identifiers

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K-285-201

Identifier Type: -

Identifier Source: org_study_id