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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).
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FS-67 patch | Active Comparator | One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days) |
|
| Placebo Patch | Placebo Comparator | One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FS-67 Patch | Drug | One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 hours of patch application on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoshinobu Higashi | Hisamitsu Pharmaceutical Co., Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hisamitsu Investigator Site | Birmingham | Alabama | 35209 | United States | ||
| Hisamitsu Investigator Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | Placebo Patch | One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo Patch | Other | One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days) |
|
|
| 8 hours of patch application on Day 1 |
| Tucson |
| Arizona |
| 85705 |
| United States |
| Hisamitsu Investigator Site | Tucson | Arizona | 85712 | United States |
| Hisamitsu Investigator Site | Hot Springs | Arkansas | 71913 | United States |
| Hisamitsu Investigator Site | Anaheim | California | 92804 | United States |
| Hisamitsu Investigator Site | Bell Gardens | California | 90201 | United States |
| Hisamitsu Investigator Site | Long Beach | California | 90806 | United States |
| Hisamitsu Investigator Site | Los Angeles | California | 90036 | United States |
| Hisamitsu Investigator Site | Boynton Beach | Florida | 33472 | United States |
| Hisamitsu Investigator Site | Daytona Beach | Florida | 32117 | United States |
| Hisamitsu Investigator Site | Doral | Florida | 33166 | United States |
| Hisamitsu Investigator Site | Jacksonville | Florida | 32216 | United States |
| Hisamitsu Investigator Site | Evansville | Indiana | 47714 | United States |
| Hisamitsu Investigator Site | Topeka | Kansas | 66604 | United States |
| Hisamitsu Investigator Site | Bellevue | Nebraska | 68005 | United States |
| Hisamitsu Investigator Site | Lincoln | Nebraska | 68510 | United States |
| Hisamitsu Investigator Site | Las Vegas | Nevada | 89106 | United States |
| Hisamitsu Investigator Site | Berlin | New Jersey | 08009 | United States |
| Hisamitsu Investigator Site | Charlotte | North Carolina | 28207 | United States |
| Hisamitsu Investigator Site | Columbus | Ohio | 43214 | United States |
| Hisamitsu Investigator Site | Dayton | Ohio | 45432 | United States |
| Hisamitsu Investigator Site | El Paso | Texas | 79902 | United States |
| Hisamitsu Investigator Site | Grapevine | Texas | 76051 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | Placebo Patch | One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 8 hours of patch application on Day 1 |
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| 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 8 hours of patch application on Day 1 |
|
3 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) | 0 | 126 | 0 | 126 | 14 | 126 |
| EG001 | Placebo Patch | One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days) | 0 | 126 | 0 | 126 | 15 | 126 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site reaction | General disorders | Systematic Assessment |
| ||
| Application site irritation | General disorders | Systematic Assessment |
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| Application site erythema | General disorders | Systematic Assessment |
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| Application site pruritus | General disorders | Systematic Assessment |
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| Oedema peripheral | General disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin disorder | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
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| Blood creatinine increased | Investigations | Systematic Assessment |
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| Influenza | Infections and infestations | Systematic Assessment |
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| Rhinitis | Infections and infestations | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | Systematic Assessment |
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| Joint sprain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yoshinobu Higashi, Section Manager, International Regulatory Affairs | Hisamitsu Pharmaceutical Co., Inc. | +81-3-5293-1712 | Yoshinobu_Higashi@hisamitsu.co.jp |
| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D057968 | Transdermal Patch |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| >=65 years |
|
| Male |
|
| Black or African American |
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| Asians |
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| European/Middle Eastern |
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| Native Hawaiian or Pacific Islander |
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| Other |
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| Units | Counts |
|---|---|
| Participants |
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