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Safety Study of Flector Patch in Children With Minor Soft Tissue Injuries

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ClinicalTrials.gov Identifier: NCT02132247
Recruitment Status : Completed
First Posted : May 7, 2014
Results First Posted : May 10, 2018
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
IBSA Institut Biochimique SA

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Athletic Injuries
Intervention Drug: Diclofenac hydroxyethylpyrrolidine
Enrollment 104
Recruitment Details  
Pre-assignment Details There were no significant events in the study between enrollment (i.e. determination of eligibility) and assignment to the Flector Patch arm.
Arm/Group Title Flector Patch/Age 6-11 Flector Patch/Age 12-16
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 52 52
Completed 51 52
Not Completed 1 0
Reason Not Completed
Protocol Violation             1             0
Arm/Group Title Flector Patch/Age 6-11 Flector Patch/Age 12-16 Total
Hide Arm/Group Description 6-11 year old participants treated with Flector Patch twice per day. 12-16 year old participants treated with Flector Patch twice per day. Total of all reporting groups
Overall Number of Baseline Participants 52 52 104
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 52 participants 104 participants
52
 100.0%
52
 100.0%
104
 100.0%
[1]
Measure Description: Eligible patients between 6 and 16 years old were enrolled in equal numbers into two subgroups, 6-11 years old and 12-16 years old.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 52 participants 104 participants
Female
14
  26.9%
22
  42.3%
36
  34.6%
Male
38
  73.1%
30
  57.7%
68
  65.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 52 participants 104 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   1.9%
1
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   3.8%
2
   1.9%
Black or African American
3
   5.8%
4
   7.7%
7
   6.7%
White
42
  80.8%
43
  82.7%
85
  81.7%
More than one race
7
  13.5%
2
   3.8%
9
   8.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 52 participants 52 participants 104 participants
52
 100.0%
52
 100.0%
104
 100.0%
Injury-Associated Pain Assessment   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 52 participants 52 participants 104 participants
3.37  (.56) 3.58  (0.64) 3.47  (0.61)
[1]
Measure Description: Wong-Baker FACES Scale: No Hurt - 0; Hurts little bit - 1; Hurts little more - 2; Hurts even more - 3; Hurts whole lot - 4; Hurts worst - 5
Height  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 52 participants 52 participants 104 participants
54.1  (4.8) 66.4  (3.5) 60.2  (7.4)
Weight  
Mean (Standard Deviation)
Unit of measure:  Pounds
Number Analyzed 52 participants 52 participants 104 participants
80.3  (28.1) 149.0  (43.6) 114.7  (50.2)
1.Primary Outcome
Title Dermatologic Assessment at the Patch Application Site
Hide Description 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.
Time Frame Up to 2 weeks, depending upon pain resolution
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Flector Patch/Age 6-11 Flector Patch/Age 12-16
Hide Arm/Group Description:
6-11 year old participants treated with Flector Patch twice per day.
12-16 year old participants treated with Flector Patch twice per day.
Overall Number of Participants Analyzed 52 52
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day1-2 0.10  (0.30) 0.04  (0.19)
Day 3-4 0.04  (0.20) 0.06  (0.24)
Day 5-7 0.11  (0.32) 0.00  (0.00)
Day 8-11 0.00  (0.00) 0.06  (0.24)
Day 12-15 0.00  (0.00) 0.00  (0.00)
2.Secondary Outcome
Title Investigator Assessment of the Global Response to Therapy on a 5-point Scale
Hide Description 5-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.
Time Frame Up to 2 weeks, depending upon pain resolution
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Flector Patch/Age 6-11 Flector Patch/Age 12-16
Hide Arm/Group Description:
6-11 year old participants treated with Flector Patch twice per day.
12-16 year old participants treated with Flector Patch twice per day.
Overall Number of Participants Analyzed 52 52
Measure Type: Count of Participants
Unit of Measure: Participants
No clinical improvement
1
   1.9%
1
   1.9%
Slight clinical improvement
0
   0.0%
0
   0.0%
Moderate clinical improvement
2
   3.8%
2
   3.8%
Marked clinical improvement
2
   3.8%
9
  17.3%
Normal function with no pain
47
  90.4%
40
  76.9%
3.Secondary Outcome
Title Patient Assessment of Pain on a 6-point Scale
Hide Description

Wong-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.

Time Frame Up to 2 weeks, depending upon pain resolution
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Flector Patch/Age 6-11 Flector Patch/Age 12-16
Hide Arm/Group Description:
6-11 year old participants treated with Flector Patch twice per day.
12-16 year old participants treated with Flector Patch twice per day.
Overall Number of Participants Analyzed 52 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 3.37  (0.56) 3.58  (0.64)
Final Visit 0.12  (0.47) 0.27  (0.66)
4.Secondary Outcome
Title Plasma Concentration of Diclofenac
Hide Description [Not Specified]
Time Frame Day 2 and either Day 4, 7 or 14, depending upon pain resolution
Hide Outcome Measure Data
Hide Analysis Population Description
One participant missed a blood draw.
Arm/Group Title Flector Patch/Age 6-11 Flector Patch/Age 12-16
Hide Arm/Group Description:
6-11 year old participants treated with Flector Patch twice per day.
12-16 year old participants treated with Flector Patch twice per day.
Overall Number of Participants Analyzed 52 51
Mean (Standard Deviation)
Unit of Measure: ng/mL
24-hour 1.83  (2.10) 1.46  (1.88)
Final Visit 2.49  (3.01) 1.11  (1.09)
Time Frame Adverse event data were collected for 2 years and 5 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Flector Patch/Age 6-11 Flector Patch/Age 12-16
Hide Arm/Group Description 6-11 year old participants treated with Flector Patch twice per day. 12-16 year old participants treated with Flector Patch twice per day.
All-Cause Mortality
Flector Patch/Age 6-11 Flector Patch/Age 12-16
Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)      0/52 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Flector Patch/Age 6-11 Flector Patch/Age 12-16
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/52 (0.00%)      0/52 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Flector Patch/Age 6-11 Flector Patch/Age 12-16
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/52 (7.69%)      10/52 (19.23%)    
Nervous system disorders     
Headache *  4/52 (7.69%)  5 5/52 (9.62%)  5
Skin and subcutaneous tissue disorders     
Pruritus   0/52 (0.00%)  0 5/52 (9.62%)  5
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christopher Jones, Ph.D.
Organization: IBSA Pharma Inc.
Phone: (202) 753-6475 ext 7005
EMail: chris.jones@ibsapharma.com
Layout table for additonal information
Responsible Party: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT02132247     History of Changes
Other Study ID Numbers: 08US/Fp03
First Submitted: April 28, 2014
First Posted: May 7, 2014
Results First Submitted: March 6, 2018
Results First Posted: May 10, 2018
Last Update Posted: May 10, 2018