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 2

Terminated

• Conditions: Acute Pain
• Interventions: Drug: K-285; Drug: Menthol

• Registration Number: NCT04484428
• Lead Sponsor: Kowa Research Institute, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-23
• Study Start: 2020-08-15
• Primary Completion: 2021-03-19
• Study Completion: 2021-03-19
• Disposition First Submitted: 2022-03-11
• Results First Submitted: 2024-03-11
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Results First Posted: 2024-12-27
• Disposition First Posted: 2024-12-27
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 126

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm A	K-285	K-285
Treatment Arm B	Menthol	Menthol

Primary Outcome Measures

Name	Time	Method
Sum of Pain Intensity Difference Between 0 to 24 Hours (SPID0-24) for Study Leg While Standing	Baseline to 24 Hours	* 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.

Secondary Outcome Measures

Name	Time	Method
SPID0-24 at Rest for Study Leg	Baseline to 24 Hours	* 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.
SPID0-12 While Standing for Study Leg	Baseline to 12 Hours	* 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.
SPID0-12 at Rest for Study Leg	Baseline to 12 Hours	* 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.
SPID0-48 While Standing for Study Leg	Baseline to 48 Hours	* 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.
SPID0-48 at Rest for Study Leg	Baseline to 48 Hours	* 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.
SPID0-72 While Standing for Study Leg	Baseline to 72 Hours	* 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.
SPID0-72 at Rest for Study Leg	Baseline to 72 Hours	* 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.

Trial Locations

Locations (1)

Lotus Clinical Research, LLC; 🇺🇸 Pasadena, California, United States