Trial Outcomes & Findings for Safety Study of Flector Patch in Children With Minor Soft Tissue Injuries (NCT NCT02132247)
NCT ID: NCT02132247
Last Updated: 2018-05-11
Results Overview
None - 0; Faint redness - 1; Moderate redness - 2; Intense redness - 3; Redness with edema or papules - 4; Redness with weeping vesicles, blisters or bullae - 5; Redness with extension of effect beyond margin of contact site - 6.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
104 participants
Primary outcome timeframe
Up to 2 weeks, depending upon pain resolution
Results posted on
2018-05-11
Participant Flow
There were no significant events in the study between enrollment (i.e. determination of eligibility) and assignment to the Flector Patch arm.
Participant milestones
| Measure |
Flector Patch/Age 6-11
Flector Patch is a topical delivery system containing 180 mg of diclofenac epolamine. The patch will be used twice-a-day for up to two weeks, or until pain resolution, whichever comes first.
|
Flector Patch/Age 12-16
Flector Patch is a topical delivery system containing 180 mg of diclofenac epolamine. The patch will be used twice-a-day for up to two weeks, or until pain resolution, whichever comes first.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
|
Overall Study
COMPLETED
|
51
|
52
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Flector Patch/Age 6-11
Flector Patch is a topical delivery system containing 180 mg of diclofenac epolamine. The patch will be used twice-a-day for up to two weeks, or until pain resolution, whichever comes first.
|
Flector Patch/Age 12-16
Flector Patch is a topical delivery system containing 180 mg of diclofenac epolamine. The patch will be used twice-a-day for up to two weeks, or until pain resolution, whichever comes first.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Safety Study of Flector Patch in Children With Minor Soft Tissue Injuries
Baseline characteristics by cohort
| Measure |
Flector Patch/Age 6-11
n=52 Participants
6-11 year old participants treated with Flector Patch twice per day.
|
Flector Patch/Age 12-16
n=52 Participants
12-16 year old participants treated with Flector Patch twice per day.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
52 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Injury-Associated Pain Assessment
|
3.37 units on a scale
STANDARD_DEVIATION .56 • n=5 Participants
|
3.58 units on a scale
STANDARD_DEVIATION 0.64 • n=7 Participants
|
3.47 units on a scale
STANDARD_DEVIATION 0.61 • n=5 Participants
|
|
Height
|
54.1 Inches
STANDARD_DEVIATION 4.8 • n=5 Participants
|
66.4 Inches
STANDARD_DEVIATION 3.5 • n=7 Participants
|
60.2 Inches
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Weight
|
80.3 Pounds
STANDARD_DEVIATION 28.1 • n=5 Participants
|
149.0 Pounds
STANDARD_DEVIATION 43.6 • n=7 Participants
|
114.7 Pounds
STANDARD_DEVIATION 50.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 weeks, depending upon pain resolutionNone - 0; Faint redness - 1; Moderate redness - 2; Intense redness - 3; Redness with edema or papules - 4; Redness with weeping vesicles, blisters or bullae - 5; Redness with extension of effect beyond margin of contact site - 6.
Outcome measures
| Measure |
Flector Patch/Age 6-11
n=52 Participants
6-11 year old participants treated with Flector Patch twice per day.
|
Flector Patch/Age 12-16
n=52 Participants
12-16 year old participants treated with Flector Patch twice per day.
|
|---|---|---|
|
Dermatologic Assessment at the Patch Application Site
Day 3-4
|
0.04 Units on a scale
Standard Deviation 0.20
|
0.06 Units on a scale
Standard Deviation 0.24
|
|
Dermatologic Assessment at the Patch Application Site
Day1-2
|
0.10 Units on a scale
Standard Deviation 0.30
|
0.04 Units on a scale
Standard Deviation 0.19
|
|
Dermatologic Assessment at the Patch Application Site
Day 5-7
|
0.11 Units on a scale
Standard Deviation 0.32
|
0.00 Units on a scale
Standard Deviation 0.00
|
|
Dermatologic Assessment at the Patch Application Site
Day 8-11
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.06 Units on a scale
Standard Deviation 0.24
|
|
Dermatologic Assessment at the Patch Application Site
Day 12-15
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.00 Units on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Up to 2 weeks, depending upon pain resolution5-point scale: No clinical improvement in pain intensity and/or functional performance - 1; Slight clinical improvement in pain intensity and/or functional performance - 2; Moderate clinical improvement in pain intensity and/or functional performance - 3; Marked clinical improvement in pain intensity and/or functional performance - 4; Restoration of normal functional performance in the absence of any pain - 5.
Outcome measures
| Measure |
Flector Patch/Age 6-11
n=52 Participants
6-11 year old participants treated with Flector Patch twice per day.
|
Flector Patch/Age 12-16
n=52 Participants
12-16 year old participants treated with Flector Patch twice per day.
|
|---|---|---|
|
Investigator Assessment of the Global Response to Therapy on a 5-point Scale
No clinical improvement
|
1 Participants
|
1 Participants
|
|
Investigator Assessment of the Global Response to Therapy on a 5-point Scale
Slight clinical improvement
|
0 Participants
|
0 Participants
|
|
Investigator Assessment of the Global Response to Therapy on a 5-point Scale
Moderate clinical improvement
|
2 Participants
|
2 Participants
|
|
Investigator Assessment of the Global Response to Therapy on a 5-point Scale
Marked clinical improvement
|
2 Participants
|
9 Participants
|
|
Investigator Assessment of the Global Response to Therapy on a 5-point Scale
Normal function with no pain
|
47 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Up to 2 weeks, depending upon pain resolutionWong-Baker FACES Scale 6-point scale: No Hurt - 0; Hurts Little Bit - 1; Hurts Little More - 2; Hurts Even More - 3; Hurts Whole Lot - 4; Hurts Worst - 5.
Outcome measures
| Measure |
Flector Patch/Age 6-11
n=52 Participants
6-11 year old participants treated with Flector Patch twice per day.
|
Flector Patch/Age 12-16
n=52 Participants
12-16 year old participants treated with Flector Patch twice per day.
|
|---|---|---|
|
Patient Assessment of Pain on a 6-point Scale
Baseline
|
3.37 units on a scale
Standard Deviation 0.56
|
3.58 units on a scale
Standard Deviation 0.64
|
|
Patient Assessment of Pain on a 6-point Scale
Final Visit
|
0.12 units on a scale
Standard Deviation 0.47
|
0.27 units on a scale
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Day 2 and either Day 4, 7 or 14, depending upon pain resolutionPopulation: One participant missed a blood draw.
Outcome measures
| Measure |
Flector Patch/Age 6-11
n=52 Participants
6-11 year old participants treated with Flector Patch twice per day.
|
Flector Patch/Age 12-16
n=51 Participants
12-16 year old participants treated with Flector Patch twice per day.
|
|---|---|---|
|
Plasma Concentration of Diclofenac
24-hour
|
1.83 ng/mL
Standard Deviation 2.10
|
1.46 ng/mL
Standard Deviation 1.88
|
|
Plasma Concentration of Diclofenac
Final Visit
|
2.49 ng/mL
Standard Deviation 3.01
|
1.11 ng/mL
Standard Deviation 1.09
|
Adverse Events
Flector Patch/Age 6-11
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Flector Patch/Age 12-16
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Flector Patch/Age 6-11
n=52 participants at risk
6-11 year old participants treated with Flector Patch twice per day.
|
Flector Patch/Age 12-16
n=52 participants at risk
12-16 year old participants treated with Flector Patch twice per day.
|
|---|---|---|
|
Nervous system disorders
Headache
|
7.7%
4/52 • Number of events 5 • Adverse event data were collected for 2 years and 5 months.
|
9.6%
5/52 • Number of events 5 • Adverse event data were collected for 2 years and 5 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/52 • Adverse event data were collected for 2 years and 5 months.
|
9.6%
5/52 • Number of events 5 • Adverse event data were collected for 2 years and 5 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER