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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02132247
Other study ID # 08US/Fp03
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 2014
Est. completion date May 2017

Study information

Verified date April 2018
Source IBSA Institut Biochimique SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date May 2017
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 6 Years to 16 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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

Study Design


Intervention

Drug:
Diclofenac hydroxyethylpyrrolidine


Locations

Country Name City State
United States Arlington Family Research Center Inc. Arlington Texas
United States Pediatric Research of Charlottesville Charlottesville Virginia
United States Applied Research Center of Arkansas Little Rock Arkansas
United States Pediatrics and Adolescent Medicine P.A. Marietta Georgia
United States Utah Valley Pediatrics Orem Utah
United States SCORE Physician Alliance Saint Petersburg Florida
United States J. Lewis Research Inc./FirstMed East Salt Lake City Utah
United States J. Lewis Research Inc./Foothill Family Clinic South Salt Lake City Utah
United States J. Lewis Research Inc./Foothill Family Clininc Salt Lake City Utah
United States Legacy Point Family Medicine West Point Utah

Sponsors (1)

Lead Sponsor Collaborator
IBSA Institut Biochimique SA

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. Up to 2 weeks, depending upon pain resolution
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. Up to 2 weeks, depending upon pain resolution
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.
Up to 2 weeks, depending upon pain resolution
Secondary Plasma Concentration of Diclofenac Day 2 and either Day 4, 7 or 14, depending upon pain resolution
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