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

Phase 2TerminatedNCT04484428

Kowa Research Institute, Inc.126 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

126

Conditions

Acute Pain

Interventions

K-285DRUG

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.

MentholDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Lotus Clinical Research, LLC

Pasadena, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 24 Hours

Secondary Outcomes

SPID0-24 at Rest for Study Leg

* Pain Intensity (PI) was assessed at rest for study leg 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.

Time frame: Baseline to 24 Hours

SPID0-12 While Standing for Study Leg

* Pain Intensity (PI) was assessed while standing for study leg 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 12 hours after initiating treatment (SPID12). SPID12 derived from pain scores assessed over 12 hours on a 0 -100 point scale. SPID12 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.

Data from ClinicalTrials.gov

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Time frame: Baseline to 12 Hours

SPID0-12 at Rest for Study Leg

* Pain Intensity (PI) was assessed at rest for study leg 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 12 hours after initiating treatment (SPID12). SPID12 derived from pain scores assessed over 12 hours on a 0 -100 point scale. SPID12 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.

Time frame: Baseline to 12 Hours

SPID0-48 While Standing for Study Leg

* Pain Intensity (PI) was assessed while standing for study leg 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 48 hours after initiating treatment (SPID48). SPID48 derived from pain scores assessed over 48 hours on a 0 -100 point scale. SPID48 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.

Time frame: Baseline to 48 Hours

SPID0-48 at Rest for Study Leg

* Pain Intensity (PI) was assessed at rest for study leg 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 48 hours after initiating treatment (SPID48). SPID48 derived from pain scores assessed over 48 hours on a 0 -100 point scale. SPID48 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.

Time frame: Baseline to 48 Hours

SPID0-72 While Standing for Study Leg

* Pain Intensity (PI) was assessed while standing for study leg 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 72 hours after initiating treatment (SPID72). SPID72 derived from pain scores assessed over 72 hours on a 0 -100 point scale. SPID72 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.

Time frame: Baseline to 72 Hours

SPID0-72 at Rest for Study Leg

* Pain Intensity (PI) was assessed at rest for study leg 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 72 hours after initiating treatment (SPID72). SPID72 derived from pain scores assessed over 72 hours on a 0 -100 point scale. SPID72 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.

Time frame: Baseline to 72 Hours