Athletic InjuriesPhase 4NCT02132247
Safety Study of Flector Patch in Children With Minor Soft Tissue Injuries
A Phase 4 study testing Diclofenac hydroxyethylpyrrolidine in people with Athletic Injuries, run by IBSA Institut Biochimique SA at 10 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Athletic Injuries
- What is being tested?
- Diclofenac hydroxyethylpyrrolidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 10 sitesUnited States
- Study dates
- May 2014to May 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 to 16 years, either gender
- Informed consent: 6-9 year olds must have their parent/legally authorized representative complete a Parental Permission Form; 10-16 year olds must complete a Children's Assent Form and have their parent/legally authorized representative complete a Parental Permission Form
- Minor soft tissue injury within 96 hours of study entry
- Spontaneous pain of at least moderate intensity (i.e. pain of at least 3 on the 6-point Wong- Baker Faces scale for pain severity assessment by patient)
- Injury must be considered by the Investigator to be clinically significant
- Negative urine pregnancy test at screening for female subjects of childbearing potential (started the menstrual cycle)
- Able to read and speak English
- Available with their parents for the immediate two week period following study enrollment
Who cannot join
- Major soft tissue injury (Fractures are only exclusionary if the injury is stabilized with a device, e.g. a hard cast, that cannot be removed to allow a patch to be applied to the site of injury)
- Open skin lesion or any dermatological condition (e.g. skin infection, eczema) within the injured area
- Injury is midline or involves the spine, digits or hands
- Prior injury to the same site within the past 3 months
- Three or more other prior injuries (minor or major) to the region in the past
- Injury occurred more than 96 hours prior to study entry
Show all 25Show fewer
- Prior use of topical medication to involved area within 48 hours of study entry
- Allergic disorders, including asthma or urticaria, but only if associated with exposure to aspirin or an NSAID
- Coagulation defects
- Prior use of over-the-counter (OTC) analgesics or short-acting non-steroidal anti-inflammatory drugs (NSAIDs [ibuprofen, ketoprofen]) within 6 hours of study entry (acetaminophen permitted up until the time of study entry)
- Prior use of narcotic analgesics within 7 days of study entry
- Prior use of systemic anti-inflammatory steroidal drugs within 60 days of study entry
- Prior use of long-acting NSAIDs such as piroxicam or naproxen since injury
- Concomitant use of drugs which may be susceptible to interactions with diclofenac, or affect safety if used concomitantly (serotonin-selective reuptake inhibitors (SSRI), lithium, digoxin, anticoagulants, antidiabetic agents, cyclosporin, methotrexate, quinolone antimicrobials, other NSAIDs, steroids and diuretics)
- Subjects suffering from psychiatric disorders (including depression)
- Handicapped patients, but only if the handicap prevents them from either assessing their pain or safely using the patch (e.g., pervasive developmental disorders such as autism, Asperger syndrome, Rett syndrome, Heller's syndrome, severe attention deficit hyperactivity disorders (ADHD), other severe mental retardation of traumatic, congenital or other origin)
- History of current alcohol or drug abuse dated < 1 year
- Severe cardiac, renal or hepatic impairment
- Severe systemic diseases (e.g. cancer, severe acute infection)
- Any underlying disease or medication that severely compromise the patient's immune system
- Prior history of any chronic pain disorder
- Prior history of GI bleeds/ulcers, liver or kidney disease
- Hypersensitivity to diclofenac or other NSAID drugs (including aspirin)
- Females who are pregnant or breast feeding
- Patients participating or having been involved in other clinical investigations during the three months preceding the entry of this study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Arlington Family Research Center Inc.
Arlington, Texas, 76012
Pediatric Research of Charlottesville
Charlottesville, Virginia, 22902
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
Pediatrics and Adolescent Medicine P.A.
Marietta, Georgia, 30062
Utah Valley Pediatrics
Orem, Utah, 84057
J. Lewis Research Inc./Foothill Family Clininc
Salt Lake City, Utah, 84109
J. Lewis Research Inc./FirstMed East
Salt Lake City, Utah, 84121
J. Lewis Research Inc./Foothill Family Clinic South
Salt Lake City, Utah, 84121
SCORE Physician Alliance
St. Petersburg, Florida, 33710
Legacy Point Family Medicine
West Point, Utah, 84015
About this study
Official title: An Open-label, Prospective, Uncontrolled Study of the Safety and Local Tolerability of the Diclofenac Epolamine Patch (Flector Patch) in Pediatric Patients With Minor Soft Tissue Injuries
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.
- Conditions
- Athletic Injuries
- Being tested
- Diclofenac hydroxyethylpyrrolidine
- Keywords
- Minor athletic injuries, Pain, Diclofenac, Topical
- Medical subject headings
- Athletic Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac hydroxyethylpyrrolidineDrug
Also called Flector Patch
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Diclofenac hydroxyethylpyrrolidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 weeks, depending upon pain resolution
Secondary outcomes (3)
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.
Measured: 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.
Measured: Up to 2 weeks, depending upon pain resolution
Plasma Concentration of Diclofenac
Measured: Day 2 and either Day 4, 7 or 14, depending upon pain resolution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Athletic InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSA Institut Biochimique SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clarence Jones, Ph.D., Study director, IBSA Institut Biochimique SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132247
- Sponsor's protocol ID
- 08US/Fp03
- Status last verified
- Apr 2018
- First submitted
- 28 Apr 2014
- Last updated
- 11 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 34826122
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Prospective, Uncontrolled Study of the Safety and Local Tolerability of the Diclofenac Epolamine Patch (Flector Patch) in Pediatric Patients With Minor Soft Tissue Injuries
- ClinicalTrials.gov ID
- NCT02132247
- Acronym / sponsor ID
- 08US/Fp03
- Conditions
- Athletic Injuries
- Keywords
- Minor athletic injuries, Pain, Diclofenac, Topical
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
- Study start
- May 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 7 May 2014 (estimated)
- Results
- Posted 11 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flector Patch | Experimental | Drug: Diclofenac hydroxyethylpyrrolidineFlector 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. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age 6 to 16 years, either gender
- Informed consent: 6-9 year olds must have their parent/legally authorized representative complete a Parental Permission Form; 10-16 year olds must complete a Children's Assent Form and have their parent/legally authorized representative complete a Parental Permission Form
- Minor soft tissue injury within 96 hours of study entry
- Spontaneous pain of at least moderate intensity (i.e. pain of at least 3 on the 6-point Wong- Baker Faces scale for pain severity assessment by patient)
- Injury must be considered by the Investigator to be clinically significant
Key exclusion criteria (25 listed)
- Major soft tissue injury (Fractures are only exclusionary if the injury is stabilized with a device, e.g. a hard cast, that cannot be removed to allow a patch to be applied to the site of injury)
- Open skin lesion or any dermatological condition (e.g. skin infection, eczema) within the injured area
- Injury is midline or involves the spine, digits or hands
- Prior injury to the same site within the past 3 months
- Three or more other prior injuries (minor or major) to the region in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diclofenac hydroxyethylpyrrolidineAlso: Flector Patch | Drug | Flector Patch |
Primary outcome
Dermatologic Assessment at the Patch Application Site
Time frame: Up to 2 weeks, depending upon pain resolution
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.
3 secondary outcomes
Investigator Assessment of the Global Response to Therapy on a 5-point Scale
Time frame: Up to 2 weeks, depending upon pain resolution
Patient Assessment of Pain on a 6-point Scale
Time frame: Up to 2 weeks, depending upon pain resolution
Plasma Concentration of Diclofenac
Time frame: Day 2 and either Day 4, 7 or 14, depending upon pain resolution
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34826122Jones 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clarence Jones, Ph.D. study director
IBSA Institut Biochimique SA
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diclofenac hydroxyethylpyrrolidine in people with Athletic Injuries, run by IBSA Institut Biochimique SA at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermatologic Assessment at the Patch Application Site (time frame: Up to 2 weeks, depending upon pain resolution). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02132247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.