Ankle Sprain
Conditions
Keywords
Ankle Sprain
Brief summary
The objective of this study is assess the efficacy and safety of single and multiple applications of the FS-67 patch in the treatment of ankle sprain in pediatric population (ages 13-17).
Detailed description
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain
Interventions
DRUGFS-67 Patch
One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
OTHERPlacebo Patch
One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
Sponsors
Hisamitsu Pharmaceutical Co., Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Grade 1 or Grade 2 ankle sprain
Exclusion criteria
* Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary: Sum of Pain Intensity Difference (SPID) at 8-hours (SPID8) Upon Monopodal Weight Bearing. | 8 hours of patch application on Day 1 | Summed Pain Intensity Differences (SPID8) worst observation carried forward (WOCF) during monopodal weight-bearing on the affected ankle observed at specified time-points (1, 2, 4, 6, & 8 hrs) after patch application. The SPID8 (WOCF) is a time-weighted sum of the pain intensity differences (PID), which were calculated as change from pain intensity at baseline to pain intensity at specified time points. Pain intensity was evaluated by means of a 100 mm visual analog scale (VAS), on which 0 mm represented no pain and 100 mm represented the worst pain imaginable. SPID8 was derived as the time-weighted sum (area under the curve) of the PID, where the weight assigned to each PID score is equal to the elapsed time (in hrs) since the previous scheduled evaluation time point. Five time-points were observed to calculate SPID8 therefore the potential SPID8 scores could range from -500 to +500 with negative values indicating increased pain over 8 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sum of Pain Intensity Difference at 8-hours (SPID8) at Rest. | 8 hours of patch application on Day 1 | Summed Pain Intensity Differences (SPID8) worst observation carried forward (WOCF) at rest observed at specified time-points (1, 2, 4, 6, & 8 hrs) after patch application. The SPID8 (WOCF) is a time-weighted sum of the pain intensity differences (PID), which were calculated as change from pain intensity at baseline to pain intensity at specified time points. Pain intensity was evaluated by means of a 100 mm visual analog scale (VAS), on which 0 mm represented no pain and 100 mm represented the worst pain imaginable. SPID8 was derived as the time-weighted sum (area under the curve) of the PID, where the weight assigned to each PID score is equal to the elapsed time (in hrs) since the previous scheduled evaluation time point. Five time-points were observed to calculate SPID8 therefore the potential SPID8 scores could range from -500 to +500 with negative values indicating increased pain over 8 hours. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FS-67 Patch One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days) | 126 |
| Placebo Patch One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days) | 126 |
| Total | 252 |
Baseline characteristics
| Characteristic | FS-67 Patch | Placebo Patch | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 126 Participants | 126 Participants | 252 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asians | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 18 Participants | 23 Participants | 41 Participants |
| Race/Ethnicity, Customized Caucasians | 97 Participants | 91 Participants | 188 Participants |
| Race/Ethnicity, Customized European/Middle Eastern | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 7 Participants | 7 Participants | 14 Participants |
| Region of Enrollment United States | 126 participants | 126 participants | 252 participants |
| Sex: Female, Male Female | 51 Participants | 49 Participants | 100 Participants |
| Sex: Female, Male Male | 75 Participants | 77 Participants | 152 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 126 | 0 / 126 |
| other Total, other adverse events | 14 / 126 | 15 / 126 |
| serious Total, serious adverse events | 0 / 126 | 0 / 126 |
Outcome results
Primary
Primary: Sum of Pain Intensity Difference (SPID) at 8-hours (SPID8) Upon Monopodal Weight Bearing.
Summed Pain Intensity Differences (SPID8) worst observation carried forward (WOCF) during monopodal weight-bearing on the affected ankle observed at specified time-points (1, 2, 4, 6, & 8 hrs) after patch application. The SPID8 (WOCF) is a time-weighted sum of the pain intensity differences (PID), which were calculated as change from pain intensity at baseline to pain intensity at specified time points. Pain intensity was evaluated by means of a 100 mm visual analog scale (VAS), on which 0 mm represented no pain and 100 mm represented the worst pain imaginable. SPID8 was derived as the time-weighted sum (area under the curve) of the PID, where the weight assigned to each PID score is equal to the elapsed time (in hrs) since the previous scheduled evaluation time point. Five time-points were observed to calculate SPID8 therefore the potential SPID8 scores could range from -500 to +500 with negative values indicating increased pain over 8 hours.
Time frame: 8 hours of patch application on Day 1
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| FS-67 Patch | Primary: Sum of Pain Intensity Difference (SPID) at 8-hours (SPID8) Upon Monopodal Weight Bearing. | 107.19 units on a scale | Standard Error 9.05 |
| Placebo Patch | Primary: Sum of Pain Intensity Difference (SPID) at 8-hours (SPID8) Upon Monopodal Weight Bearing. | 89.13 units on a scale | Standard Error 9.42 |
Comparison: The treatment effect of the FS-67 patch was estimated by computing the difference in LS means of the FS-67 and placebo patches from the ANCOVA modelp-value: 0.137ANCOVA
Secondary
Sum of Pain Intensity Difference at 8-hours (SPID8) at Rest.
Summed Pain Intensity Differences (SPID8) worst observation carried forward (WOCF) at rest observed at specified time-points (1, 2, 4, 6, & 8 hrs) after patch application. The SPID8 (WOCF) is a time-weighted sum of the pain intensity differences (PID), which were calculated as change from pain intensity at baseline to pain intensity at specified time points. Pain intensity was evaluated by means of a 100 mm visual analog scale (VAS), on which 0 mm represented no pain and 100 mm represented the worst pain imaginable. SPID8 was derived as the time-weighted sum (area under the curve) of the PID, where the weight assigned to each PID score is equal to the elapsed time (in hrs) since the previous scheduled evaluation time point. Five time-points were observed to calculate SPID8 therefore the potential SPID8 scores could range from -500 to +500 with negative values indicating increased pain over 8 hours.
Time frame: 8 hours of patch application on Day 1
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| FS-67 Patch | Sum of Pain Intensity Difference at 8-hours (SPID8) at Rest. | 111.98 units on a scale | Standard Error 9.28 |
| Placebo Patch | Sum of Pain Intensity Difference at 8-hours (SPID8) at Rest. | 86.89 units on a scale | Standard Error 9.65 |
p-value: 0.044ANCOVA