| 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.
|
- 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.
| Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline to 24 Hours | Legs | Legs | | ID | Title | Description |
|---|
| OG000 | K-285 | K-285 gel for up to 3 weeks based on pre-specified treatment assignments | | OG001 | Menthol Gel | Menthol gel for up to 3 weeks based on pre-specified treatment assignments |
| | Units | Counts |
|---|
| Participants | | | Legs | |
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-488.0± 58.54
- OG001-512.0± 58.53
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | 0.773 | | | | | | | | | | | | | | Superiority | | |
|
| 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.
|
- 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.
| Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline to 24 Hours | Legs | Legs | | ID | Title | Description |
|---|
| OG000 | K-285 | K-285 gel for up to 3 weeks based on pre-specified treatment assignments | |
|
| 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.
|
- 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.
| Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline to 12 Hours | Legs | Legs | | ID | Title | Description |
|---|
| OG000 | K-285 | K-285 gel for up to 3 weeks based on pre-specified treatment assignments | |
|
| 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.
|
- 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.
| Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline to 12 Hours | Legs | Legs | | ID | Title | Description |
|---|
| OG000 | K-285 | K-285 gel for up to 3 weeks based on pre-specified treatment assignments | |
|
| 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.
|
- 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.
| Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline to 48 Hours | Legs | Legs | | ID | Title | Description |
|---|
| OG000 | K-285 | K-285 gel for up to 3 weeks based on pre-specified treatment assignments | |
|
| 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.
|
- 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.
| Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline to 48 Hours | Legs | Legs | | ID | Title | Description |
|---|
| OG000 | K-285 | K-285 gel for up to 3 weeks based on pre-specified treatment assignments | |
|
| 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.
|
- 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.
| Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline to 72 Hours | Legs | Legs | | ID | Title | Description |
|---|
| OG000 | K-285 | K-285 gel for up to 3 weeks based on pre-specified treatment assignments | |
|
| 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.
|
- 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.
| Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline to 72 Hours | Legs | Legs | | ID | Title | Description |
|---|
| OG000 | K-285 | K-285 gel for up to 3 weeks based on pre-specified treatment assignments | |
|