Trial Outcomes & Findings for 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 NCT04484428)
NCT ID: NCT04484428
Last Updated: 2024-12-27
Results Overview
* 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.
TERMINATED
PHASE2
126 participants
Baseline to 24 Hours
2024-12-27
Participant Flow
Participants underwent pre- and post-exercise evaluations, as well as other screening assessments, to determine eligibility for randomization. Those qualifying were randomly assigned in a 1:1 ratio to Treatment Arm A (K-285 gel) or Treatment Arm B (Menthol gel). All baseline, endpoint, and safety analyses were conducted based on the treatment arm participants were randomized to. Participants not qualifying for randomization were given appropriate standard of care.
Participant milestones
| Measure |
K-285
K-285 gel for up to 3 weeks based on pre-specified treatment assignments.
|
Menthol
Menthol gel for up to 3 weeks based on pre-specified treatment assignments.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
63
|
|
Overall Study
COMPLETED
|
56
|
60
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The analysis was based on participants' self-reported pain intensity scores in the study leg.
Baseline characteristics by cohort
| Measure |
K-285
n=126 Legs
K-285 gel for up to 3 weeks based on pre-specified treatment assignments.
|
Menthol
n=126 Legs
Menthol gel for up to 3 weeks based on pre-specified treatment assignments.
|
Total
n=252 Legs
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.4 years
STANDARD_DEVIATION 4.89 • n=63 Participants
|
27.2 years
STANDARD_DEVIATION 4.39 • n=63 Participants
|
27.8 years
STANDARD_DEVIATION 4.67 • n=126 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=63 Participants
|
31 Participants
n=63 Participants
|
61 Participants
n=126 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=63 Participants
|
32 Participants
n=63 Participants
|
65 Participants
n=126 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=63 Participants
|
23 Participants
n=63 Participants
|
45 Participants
n=126 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=63 Participants
|
40 Participants
n=63 Participants
|
81 Participants
n=126 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=63 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=126 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=63 Participants
|
1 Participants
n=63 Participants
|
1 Participants
n=126 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=63 Participants
|
11 Participants
n=63 Participants
|
25 Participants
n=126 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=63 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=126 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=63 Participants
|
18 Participants
n=63 Participants
|
28 Participants
n=126 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=63 Participants
|
30 Participants
n=63 Participants
|
69 Participants
n=126 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=63 Participants
|
3 Participants
n=63 Participants
|
3 Participants
n=126 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=63 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=126 Participants
|
|
Qualifying (Baseline) eVAS Score for Study Leg while Standing
|
71.4 Points
STANDARD_DEVIATION 13.94 • n=63 Legs • The analysis was based on participants' self-reported pain intensity scores in the study leg.
|
69.1 Points
STANDARD_DEVIATION 13.58 • n=63 Legs • The analysis was based on participants' self-reported pain intensity scores in the study leg.
|
70.2 Points
STANDARD_DEVIATION 13.76 • n=126 Legs • The analysis was based on participants' self-reported pain intensity scores in the study leg.
|
|
Qualifying (Baseline) eVAS Score for Study Leg at Rest
|
62 Points
STANDARD_DEVIATION 15.14 • n=63 Legs • The analysis was based on participants' self-reported pain intensity scores in the study leg.
|
57.5 Points
STANDARD_DEVIATION 15.51 • n=63 Legs • The analysis was based on participants' self-reported pain intensity scores in the study leg.
|
59.8 Points
STANDARD_DEVIATION 15.43 • n=126 Legs • The analysis was based on participants' self-reported pain intensity scores in the study leg.
|
|
Qualifying (Baseline) eVAS Score for Non-Study Leg while Standing
|
69.8 Points
STANDARD_DEVIATION 16.77 • n=63 Legs • The analysis was based on participants' self-reported pain intensity scores in the non-study leg.
|
68.2 Points
STANDARD_DEVIATION 16.38 • n=63 Legs • The analysis was based on participants' self-reported pain intensity scores in the non-study leg.
|
69 Points
STANDARD_DEVIATION 16.53 • n=126 Legs • The analysis was based on participants' self-reported pain intensity scores in the non-study leg.
|
|
Qualifying (Baseline) eVAS Score for Non-Study Leg at Rest
|
59.1 Points
STANDARD_DEVIATION 18.77 • n=63 Legs • The analysis was based on participants' self-reported pain intensity scores in the non-study leg.
|
54.7 Points
STANDARD_DEVIATION 19.44 • n=63 Legs • The analysis was based on participants' self-reported pain intensity scores in the non-study leg.
|
56.9 Points
STANDARD_DEVIATION 19.16 • n=126 Legs • The analysis was based on participants' self-reported pain intensity scores in the non-study leg.
|
PRIMARY outcome
Timeframe: Baseline to 24 HoursPopulation: * Subjects in each treatment Arm/Group (K-285 and Menthol Gel) received intervention based on pre-specified treatment assignments * Baseline and Endpoint analysis were performed and presented by treatment Arms/Groups. * Demographics and baseline characteristics are presented in a by-subject listing and summarized overall and by treatment Arm using the FAS. * All 126 participants (100.0%) were included in the FAS, the PPS, and Safety populations.
* 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.
Outcome measures
| Measure |
K-285
n=63 Legs
K-285 gel for up to 3 weeks based on pre-specified treatment assignments
|
Menthol Gel
n=63 Legs
Menthol gel for up to 3 weeks based on pre-specified treatment assignments
|
|---|---|---|
|
Sum of Pain Intensity Difference Between 0 to 24 Hours (SPID0-24) for Study Leg While Standing
|
-488.0 score on a scale
Standard Error 58.54
|
-512.0 score on a scale
Standard Error 58.53
|
SECONDARY outcome
Timeframe: Baseline to 24 HoursPopulation: * Subjects in each treatment Arm/Group (K-285 and Menthol Gel) received intervention based on pre-specified treatment assignments * Baseline and Endpoint analysis were performed and presented by treatment Arms/Groups. * Demographics and baseline characteristics are presented in a by-subject listing and summarized overall and by treatment Arm using the FAS. * All 126 participants (100.0%) were included in the FAS, the PPS, and Safety populations.
* 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.
Outcome measures
| Measure |
K-285
n=63 Legs
K-285 gel for up to 3 weeks based on pre-specified treatment assignments
|
Menthol Gel
n=63 Legs
Menthol gel for up to 3 weeks based on pre-specified treatment assignments
|
|---|---|---|
|
SPID0-24 at Rest for Study Leg
|
-358.3 score on a scale
Standard Error 54.42
|
-355.6 score on a scale
Standard Error 54.45
|
SECONDARY outcome
Timeframe: Baseline to 12 HoursPopulation: * Subjects in each treatment Arm/Group (K-285 and Menthol Gel) received intervention based on pre-specified treatment assignments * Baseline and Endpoint analysis were performed and presented by treatment Arms/Groups. * Demographics and baseline characteristics are presented in a by-subject listing and summarized overall and by treatment Arm using the FAS. * All 126 participants (100.0%) were included in the FAS, the PPS, and Safety populations.
* 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.
Outcome measures
| Measure |
K-285
n=63 Legs
K-285 gel for up to 3 weeks based on pre-specified treatment assignments
|
Menthol Gel
n=63 Legs
Menthol gel for up to 3 weeks based on pre-specified treatment assignments
|
|---|---|---|
|
SPID0-12 While Standing for Study Leg
|
-190.2 score on a scale
Standard Error 26.83
|
-209.2 score on a scale
Standard Error 26.83
|
SECONDARY outcome
Timeframe: Baseline to 12 HoursPopulation: * Subjects in each treatment Arm/Group (K-285 and Menthol Gel) received intervention based on pre-specified treatment assignments * Baseline and Endpoint analysis were performed and presented by treatment Arms/Groups. * Demographics and baseline characteristics are presented in a by-subject listing and summarized overall and by treatment Arm using the FAS. * All 126 participants (100.0%) were included in the FAS, the PPS, and Safety populations.
* 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.
Outcome measures
| Measure |
K-285
n=63 Legs
K-285 gel for up to 3 weeks based on pre-specified treatment assignments
|
Menthol Gel
n=63 Legs
Menthol gel for up to 3 weeks based on pre-specified treatment assignments
|
|---|---|---|
|
SPID0-12 at Rest for Study Leg
|
-131.5 score on a scale
Standard Error 25.28
|
-140.8 score on a scale
Standard Error 25.29
|
SECONDARY outcome
Timeframe: Baseline to 48 HoursPopulation: * Subjects in each treatment Arm/Group (K-285 and Menthol Gel) received intervention based on pre-specified treatment assignments * Baseline and Endpoint analysis were performed and presented by treatment Arms/Groups. * Demographics and baseline characteristics are presented in a by-subject listing and summarized overall and by treatment Arm using the FAS. * All 126 participants (100.0%) were included in the FAS, the PPS, and Safety populations.
* 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.
Outcome measures
| Measure |
K-285
n=63 Legs
K-285 gel for up to 3 weeks based on pre-specified treatment assignments
|
Menthol Gel
n=63 Legs
Menthol gel for up to 3 weeks based on pre-specified treatment assignments
|
|---|---|---|
|
SPID0-48 While Standing for Study Leg
|
-1229.9 score on a scale
Standard Error 123.15
|
-1221.1 score on a scale
Standard Error 123.14
|
SECONDARY outcome
Timeframe: Baseline to 48 HoursPopulation: * Subjects in each treatment Arm/Group (K-285 and Menthol Gel) received intervention based on pre-specified treatment assignments * Baseline and Endpoint analysis were performed and presented by treatment Arms/Groups. * Demographics and baseline characteristics are presented in a by-subject listing and summarized overall and by treatment Arm using the FAS. * All 126 participants (100.0%) were included in the FAS, the PPS, and Safety populations.
* 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.
Outcome measures
| Measure |
K-285
n=63 Legs
K-285 gel for up to 3 weeks based on pre-specified treatment assignments
|
Menthol Gel
n=63 Legs
Menthol gel for up to 3 weeks based on pre-specified treatment assignments
|
|---|---|---|
|
SPID0-48 at Rest for Study Leg
|
-959.4 score on a scale
Standard Error 114.80
|
-909.5 score on a scale
Standard Error 114.85
|
SECONDARY outcome
Timeframe: Baseline to 72 HoursPopulation: * Subjects in each treatment Arm/Group (K-285 and Menthol Gel) received intervention based on pre-specified treatment assignments * Baseline and Endpoint analysis were performed and presented by treatment Arms/Groups. * Demographics and baseline characteristics are presented in a by-subject listing and summarized overall and by treatment Arm using the FAS. * All 126 participants (100.0%) were included in the FAS, the PPS, and Safety populations.
* 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.
Outcome measures
| Measure |
K-285
n=63 Legs
K-285 gel for up to 3 weeks based on pre-specified treatment assignments
|
Menthol Gel
n=63 Legs
Menthol gel for up to 3 weeks based on pre-specified treatment assignments
|
|---|---|---|
|
SPID0-72 While Standing for Study Leg
|
-2154.1 score on a scale
Standard Error 184.65
|
-2160.8 score on a scale
Standard Error 184.64
|
SECONDARY outcome
Timeframe: Baseline to 72 HoursPopulation: * Subjects in each treatment Arm/Group (K-285 and Menthol Gel) received intervention based on pre-specified treatment assignments * Baseline and Endpoint analysis were performed and presented by treatment Arms/Groups. * Demographics and baseline characteristics are presented in a by-subject listing and summarized overall and by treatment Arm using the FAS. * All 126 participants (100.0%) were included in the FAS, the PPS, and Safety populations.
* 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.
Outcome measures
| Measure |
K-285
n=63 Legs
K-285 gel for up to 3 weeks based on pre-specified treatment assignments
|
Menthol Gel
n=63 Legs
Menthol gel for up to 3 weeks based on pre-specified treatment assignments
|
|---|---|---|
|
SPID0-72 at Rest for Study Leg
|
-1730.1 score on a scale
Standard Error 169.61
|
-1678.3 score on a scale
Standard Error 169.68
|
Adverse Events
K-285
Menthol Gel
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
K-285
n=63 participants at risk
K-285 gel for up to 3 weeks based on pre-specified treatment assignments
|
Menthol Gel
n=63 participants at risk
Menthol gel for up to 3 weeks based on pre-specified treatment assignments
|
|---|---|---|
|
General disorders
Application site erythema
|
6.3%
4/63 • Up to 29 Days
* The Safety Set included all participants who had at least 1 study gel application. * The safety analyses were conducted based on the treatment group (K-285 or Menthol gel) participants were randomized to. * Adverse Event information was assessed according to the treatment Arm/Group and not treatment schedules, as pre-specified in the SAP * Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
1.6%
1/63 • Up to 29 Days
* The Safety Set included all participants who had at least 1 study gel application. * The safety analyses were conducted based on the treatment group (K-285 or Menthol gel) participants were randomized to. * Adverse Event information was assessed according to the treatment Arm/Group and not treatment schedules, as pre-specified in the SAP * Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
|
General disorders
Application site pruritus
|
6.3%
4/63 • Up to 29 Days
* The Safety Set included all participants who had at least 1 study gel application. * The safety analyses were conducted based on the treatment group (K-285 or Menthol gel) participants were randomized to. * Adverse Event information was assessed according to the treatment Arm/Group and not treatment schedules, as pre-specified in the SAP * Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
0.00%
0/63 • Up to 29 Days
* The Safety Set included all participants who had at least 1 study gel application. * The safety analyses were conducted based on the treatment group (K-285 or Menthol gel) participants were randomized to. * Adverse Event information was assessed according to the treatment Arm/Group and not treatment schedules, as pre-specified in the SAP * Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
|
Additional Information
Director, Clinical Operations
Kowa Research Institute, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place