Trial Outcomes & Findings for FS-67 in the Treatment of Pediatric Patients With Ankle Sprain (NCT NCT01037816)
NCT ID: NCT01037816
Last Updated: 2022-10-06
Results Overview
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.
COMPLETED
PHASE4
252 participants
8 hours of patch application on Day 1
2022-10-06
Participant Flow
Participant milestones
| Measure |
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)
|
Placebo Patch
One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
126
|
|
Overall Study
COMPLETED
|
124
|
126
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FS-67 in the Treatment of Pediatric Patients With Ankle Sprain
Baseline characteristics by cohort
| Measure |
FS-67 Patch
n=126 Participants
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
n=126 Participants
One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
126 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasians
|
97 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asians
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
European/Middle Eastern
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
126 participants
n=5 Participants
|
126 participants
n=7 Participants
|
252 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 hours of patch application on Day 1Summed 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.
Outcome measures
| Measure |
FS-67 Patch
n=126 Participants
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
n=126 Participants
One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
|
|---|---|---|
|
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
|
89.13 units on a scale
Standard Error 9.42
|
SECONDARY outcome
Timeframe: 8 hours of patch application on Day 1Summed 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.
Outcome measures
| Measure |
FS-67 Patch
n=126 Participants
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
n=126 Participants
One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
|
|---|---|---|
|
Sum of Pain Intensity Difference at 8-hours (SPID8) at Rest.
|
111.98 units on a scale
Standard Error 9.28
|
86.89 units on a scale
Standard Error 9.65
|
Adverse Events
FS-67 Patch
Placebo Patch
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FS-67 Patch
n=126 participants at risk
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
n=126 participants at risk
One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
|
|---|---|---|
|
General disorders
Application site reaction
|
0.79%
1/126 • Number of events 2 • 3 day
|
3.2%
4/126 • Number of events 5 • 3 day
|
|
General disorders
Application site irritation
|
1.6%
2/126 • Number of events 2 • 3 day
|
0.00%
0/126 • 3 day
|
|
General disorders
Application site erythema
|
0.79%
1/126 • Number of events 1 • 3 day
|
0.79%
1/126 • Number of events 1 • 3 day
|
|
General disorders
Application site pruritus
|
0.00%
0/126 • 3 day
|
0.79%
1/126 • Number of events 2 • 3 day
|
|
General disorders
Oedema peripheral
|
0.79%
1/126 • Number of events 1 • 3 day
|
0.00%
0/126 • 3 day
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.79%
1/126 • Number of events 1 • 3 day
|
0.00%
0/126 • 3 day
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.79%
1/126 • Number of events 1 • 3 day
|
0.00%
0/126 • 3 day
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/126 • 3 day
|
0.79%
1/126 • Number of events 1 • 3 day
|
|
Investigations
Hepatic enzyme increased
|
0.79%
1/126 • Number of events 1 • 3 day
|
0.79%
1/126 • Number of events 1 • 3 day
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/126 • 3 day
|
0.79%
1/126 • Number of events 1 • 3 day
|
|
Investigations
Blood creatinine increased
|
0.00%
0/126 • 3 day
|
0.79%
1/126 • Number of events 1 • 3 day
|
|
Infections and infestations
Influenza
|
0.79%
1/126 • Number of events 1 • 3 day
|
0.00%
0/126 • 3 day
|
|
Infections and infestations
Rhinitis
|
0.79%
1/126 • Number of events 1 • 3 day
|
0.00%
0/126 • 3 day
|
|
Gastrointestinal disorders
Nausea
|
0.79%
1/126 • Number of events 1 • 3 day
|
0.00%
0/126 • 3 day
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/126 • 3 day
|
0.79%
1/126 • Number of events 1 • 3 day
|
|
Nervous system disorders
Headache
|
0.00%
0/126 • 3 day
|
1.6%
2/126 • Number of events 2 • 3 day
|
|
Immune system disorders
Hypersensitivity
|
0.79%
1/126 • Number of events 1 • 3 day
|
0.00%
0/126 • 3 day
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.79%
1/126 • Number of events 1 • 3 day
|
0.00%
0/126 • 3 day
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.79%
1/126 • Number of events 1 • 3 day
|
0.00%
0/126 • 3 day
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/126 • 3 day
|
0.79%
1/126 • Number of events 1 • 3 day
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/126 • 3 day
|
0.79%
1/126 • Number of events 1 • 3 day
|
Additional Information
Yoshinobu Higashi, Section Manager, International Regulatory Affairs
Hisamitsu Pharmaceutical Co., Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place