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

NCT04484428 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: K-285-201
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Difference Between 0 to 24 Hours (SPID0-24) for Study Leg While Standing

  * Pain Intensity (PI) was assessed for study leg while standing using a patient rated 0-100 point scale where 0 = 'no Pain' and 100 = 'worst possible pain. Pain Intensity Differences (PID) was the difference between PI at time (i) minus PI at time (t+1). The Sum of Pain Intensity Difference (SPID) was calculated as a time-weighted Sum of PID scores over a number of hours. * Sum of pain intensity differences over 24 hours after initiating treatment (SPID24). SPID24 derived from pain scores assessed over 24 hours on a 0 -100 point scale. SPID24 was computed using the trapezoidal rule, i.e. Σ \[T(i+1) - T(i)\] x \[((PID)(i+1) + PID(i))/2\] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time (i). * Negative differences correspond to an improvement of pain, while positive differences correspond to recrudescence of pain. A higher negative value of SPID indicates greater pain relief.

  Baseline to 24 Hours

Secondary Outcomes (7)

• SPID0-24 at Rest for Study Leg

  Baseline to 24 Hours

• SPID0-12 While Standing for Study Leg

  Baseline to 12 Hours

• SPID0-12 at Rest for Study Leg

  Baseline to 12 Hours

• SPID0-48 While Standing for Study Leg

  Baseline to 48 Hours

• SPID0-48 at Rest for Study Leg

  Baseline to 48 Hours

Study Arms (2)

Treatment Arm A

EXPERIMENTAL

K-285

Drug: K-285

Treatment Arm B

ACTIVE COMPARATOR

Menthol

Drug: Menthol

Interventions

K-285 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 A

Menthol 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

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kowa Research Institute, Inc.: lead

Study Sites (1)

Lotus Clinical Research, LLC

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Menthol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids

Results Point of Contact

• Title: Director, Clinical Operations
• Organization: Kowa Research Institute, Inc.

CTGResults@KowaUS.com

919-433-1600

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 23, 2020
• Study Start: August 15, 2020
• Primary Completion: March 19, 2021
• Study Completion: March 19, 2021
• Last Updated: December 27, 2024
• Results First Posted: December 27, 2024

Record last verified: 2024-12

Locations

US (1)