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The primary purpose of this study is to determine whether Flector Patch is safe for use in children. The secondary purpose is to assess blood levels of diclofenac, the active ingredient in Flector Patch.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flector Patch | Experimental | Flector Patch is a transdermal delivery system containing 180 mg of diclofenac hydroxyethylpyrrolidine. The patch will be used twice-a-day for up to two weeks, or until pain resolution, whichever comes first. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac hydroxyethylpyrrolidine | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Dermatologic Assessment at the Patch Application Site | 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. | Up to 2 weeks, depending upon pain resolution |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Assessment of the Global Response to Therapy on a 5-point Scale | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clarence Jones, Ph.D. | IBSA Institut Biochimique SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Research Center of Arkansas | Little Rock | Arkansas | 72212 | United States | ||
| SCORE Physician Alliance |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34826122 | Derived | Jones CA, Hoehler FK, Frangione V, Ledesma G, Wisman PP Jr, Jones C. Safety and Efficacy of the FLECTOR (Diclofenac Epolamine) Topical System in Children with Minor Soft Tissue Injuries: A Phase IV Non-randomized Clinical Trial. Clin Drug Investig. 2022 Jan;42(1):43-51. doi: 10.1007/s40261-021-01101-x. Epub 2021 Nov 26. |
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There were no significant events in the study between enrollment (i.e. determination of eligibility) and assignment to the Flector Patch arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Flector Patch/Age 12-16 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Up to 2 weeks, depending upon pain resolution |
| Patient Assessment of Pain on a 6-point Scale | 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. | Up to 2 weeks, depending upon pain resolution |
| Plasma Concentration of Diclofenac | Day 2 and either Day 4, 7 or 14, depending upon pain resolution |
| St. Petersburg |
| Florida |
| 33710 |
| United States |
| Pediatrics and Adolescent Medicine P.A. | Marietta | Georgia | 30062 | United States |
| Arlington Family Research Center Inc. | Arlington | Texas | 76012 | United States |
| Utah Valley Pediatrics | Orem | Utah | 84057 | United States |
| J. Lewis Research Inc./Foothill Family Clininc | Salt Lake City | Utah | 84109 | United States |
| J. Lewis Research Inc./FirstMed East | Salt Lake City | Utah | 84121 | United States |
| J. Lewis Research Inc./Foothill Family Clinic South | Salt Lake City | Utah | 84121 | United States |
| Legacy Point Family Medicine | West Point | Utah | 84015 | United States |
| Pediatric Research of Charlottesville | Charlottesville | Virginia | 22902 | United States |
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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Flector Patch/Age 6-11 | 6-11 year old participants treated with Flector Patch twice per day. |
| BG001 | Flector Patch/Age 12-16 | 12-16 year old participants treated with Flector Patch twice per day. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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. | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Injury-Associated Pain Assessment | 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 | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Height | Mean | Standard Deviation | Inches |
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| Weight | Mean | Standard Deviation | Pounds |
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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 | Dermatologic Assessment at the Patch Application Site | 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. | Posted | Mean | Standard Deviation | Units on a scale | Up to 2 weeks, depending upon pain resolution |
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| Secondary | Investigator Assessment of the Global Response to Therapy on a 5-point Scale | 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. | Posted | Count of Participants | Participants | Up to 2 weeks, depending upon pain resolution |
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| Secondary | Patient Assessment of Pain on a 6-point Scale | 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. | Posted | Mean | Standard Deviation | units on a scale | Up to 2 weeks, depending upon pain resolution |
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| Secondary | Plasma Concentration of Diclofenac | One participant missed a blood draw. | Posted | Mean | Standard Deviation | ng/mL | Day 2 and either Day 4, 7 or 14, depending upon pain resolution |
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Adverse event data were collected for 2 years and 5 months.
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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 | Flector Patch/Age 6-11 | 6-11 year old participants treated with Flector Patch twice per day. | 0 | 52 | 0 | 52 | 4 | 52 |
| EG001 | Flector Patch/Age 12-16 | 12-16 year old participants treated with Flector Patch twice per day. | 0 | 52 | 0 | 52 | 10 | 52 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Jones, Ph.D. | IBSA Pharma Inc. | (202) 753-6475 | 7005 | chris.jones@ibsapharma.com |
| ID | Term |
|---|---|
| D001265 | Athletic Injuries |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C064142 | diclofenac hydroxyethylpyrrolidine |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Day 5-7 |
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| Day 8-11 |
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| Day 12-15 |
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