Acute Pain
Conditions
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.
Interventions
DRUGK-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.
DRUGMenthol
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.
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| SPID0-24 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. |
| SPID0-72 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. |
| 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| K-285 K-285 gel for up to 3 weeks based on pre-specified treatment assignments. | 63 |
| K-285 K-285 gel for up to 3 weeks based on pre-specified treatment assignments. | 126 |
| Menthol Menthol gel for up to 3 weeks based on pre-specified treatment assignments. | 63 |
| Menthol Menthol gel for up to 3 weeks based on pre-specified treatment assignments. | 126 |
| Total | 378 |
Baseline characteristics
| Characteristic | K-285 | Menthol | Total |
|---|---|---|---|
| Age, Continuous | 28.4 years STANDARD_DEVIATION 4.89 | 27.2 years STANDARD_DEVIATION 4.39 | 27.8 years STANDARD_DEVIATION 4.67 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 23 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 40 Participants | 81 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Qualifying (Baseline) eVAS Score for Non-Study Leg at Rest | 59.1 Points STANDARD_DEVIATION 18.77 | 54.7 Points STANDARD_DEVIATION 19.44 | 56.9 Points STANDARD_DEVIATION 19.16 |
| Qualifying (Baseline) eVAS Score for Non-Study Leg while Standing | 69.8 Points STANDARD_DEVIATION 16.77 | 68.2 Points STANDARD_DEVIATION 16.38 | 69 Points STANDARD_DEVIATION 16.53 |
| Qualifying (Baseline) eVAS Score for Study Leg at Rest | 62 Points STANDARD_DEVIATION 15.14 | 57.5 Points STANDARD_DEVIATION 15.51 | 59.8 Points STANDARD_DEVIATION 15.43 |
| Qualifying (Baseline) eVAS Score for Study Leg while Standing | 71.4 Points STANDARD_DEVIATION 13.94 | 69.1 Points STANDARD_DEVIATION 13.58 | 70.2 Points STANDARD_DEVIATION 13.76 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 11 Participants | 25 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 18 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 39 Participants | 30 Participants | 69 Participants |
| Sex: Female, Male Female | 30 Participants | 31 Participants | 61 Participants |
| Sex: Female, Male Male | 33 Participants | 32 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 63 |
| other Total, other adverse events | 6 / 63 | 1 / 63 |
| serious Total, serious adverse events | 0 / 63 | 0 / 63 |
Outcome results
Primary
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
Population: * 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| K-285 | 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 |
| Menthol Gel | Sum of Pain Intensity Difference Between 0 to 24 Hours (SPID0-24) for Study Leg While Standing | -512.0 score on a scale | Standard Error 58.53 |
p-value: 0.773ANCOVA
Secondary
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
Population: * 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| K-285 | SPID0-12 at Rest for Study Leg | -131.5 score on a scale | Standard Error 25.28 |
| Menthol Gel | SPID0-12 at Rest for Study Leg | -140.8 score on a scale | Standard Error 25.29 |
p-value: 0.796ANCOVA
Secondary
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.
Time frame: Baseline to 12 Hours
Population: * 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| K-285 | SPID0-12 While Standing for Study Leg | -190.2 score on a scale | Standard Error 26.83 |
| Menthol Gel | SPID0-12 While Standing for Study Leg | -209.2 score on a scale | Standard Error 26.83 |
p-value: 0.617ANCOVA
Secondary
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
Population: * 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| K-285 | SPID0-24 at Rest for Study Leg | -358.3 score on a scale | Standard Error 54.42 |
| Menthol Gel | SPID0-24 at Rest for Study Leg | -355.6 score on a scale | Standard Error 54.45 |
p-value: 0.972ANCOVA
Secondary
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
Population: * 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| K-285 | SPID0-48 at Rest for Study Leg | -959.4 score on a scale | Standard Error 114.8 |
| Menthol Gel | SPID0-48 at Rest for Study Leg | -909.5 score on a scale | Standard Error 114.85 |
p-value: 0.761ANCOVA
Secondary
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
Population: * 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| K-285 | SPID0-48 While Standing for Study Leg | -1229.9 score on a scale | Standard Error 123.15 |
| Menthol Gel | SPID0-48 While Standing for Study Leg | -1221.1 score on a scale | Standard Error 123.14 |
p-value: 0.96ANCOVA
Secondary
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
Population: * 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| K-285 | SPID0-72 at Rest for Study Leg | -1730.1 score on a scale | Standard Error 169.61 |
| Menthol Gel | SPID0-72 at Rest for Study Leg | -1678.3 score on a scale | Standard Error 169.68 |
p-value: 0.803ANCOVA
Secondary
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
Population: * 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| K-285 | SPID0-72 While Standing for Study Leg | -2154.1 score on a scale | Standard Error 184.65 |
| Menthol Gel | SPID0-72 While Standing for Study Leg | -2160.8 score on a scale | Standard Error 184.64 |
p-value: 0.979ANCOVA