Athletic Injuries
Conditions
Keywords
Minor athletic injuries, Pain, Diclofenac, Topical
Brief 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.
Interventions
Sponsors
IBSA Institut Biochimique SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dermatologic Assessment at the Patch Application Site | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Assessment of the Global Response to Therapy on a 5-point Scale | Up to 2 weeks, depending upon pain resolution | 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. |
| Patient Assessment of Pain on a 6-point Scale | Up to 2 weeks, depending upon pain resolution | 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. |
| Plasma Concentration of Diclofenac | Day 2 and either Day 4, 7 or 14, depending upon pain resolution | — |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Flector Patch/Age 6-11 6-11 year old participants treated with Flector Patch twice per day. | 52 |
| Flector Patch/Age 12-16 12-16 year old participants treated with Flector Patch twice per day. | 52 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Flector Patch/Age 12-16 | Total | Flector Patch/Age 6-11 |
|---|---|---|---|
| Age, Customized | 52 Participants | 104 Participants | 52 Participants |
| Height | 66.4 Inches STANDARD_DEVIATION 3.5 | 60.2 Inches STANDARD_DEVIATION 7.4 | 54.1 Inches STANDARD_DEVIATION 4.8 |
| Injury-Associated Pain Assessment | 3.58 units on a scale STANDARD_DEVIATION 0.64 | 3.47 units on a scale STANDARD_DEVIATION 0.61 | 3.37 units on a scale STANDARD_DEVIATION 0.56 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 9 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 43 Participants | 85 Participants | 42 Participants |
| Region of Enrollment United States | 52 Participants | 104 Participants | 52 Participants |
| Sex: Female, Male Female | 22 Participants | 36 Participants | 14 Participants |
| Sex: Female, Male Male | 30 Participants | 68 Participants | 38 Participants |
| Weight | 149.0 Pounds STANDARD_DEVIATION 43.6 | 114.7 Pounds STANDARD_DEVIATION 50.2 | 80.3 Pounds STANDARD_DEVIATION 28.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 52 |
| other Total, other adverse events | 4 / 52 | 10 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 52 |
Outcome results
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.
Time frame: Up to 2 weeks, depending upon pain resolution
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flector Patch/Age 6-11 | Dermatologic Assessment at the Patch Application Site | Day 3-4 | 0.04 Units on a scale | Standard Deviation 0.2 |
| Flector Patch/Age 6-11 | Dermatologic Assessment at the Patch Application Site | Day 8-11 | 0.00 Units on a scale | Standard Deviation 0 |
| Flector Patch/Age 6-11 | Dermatologic Assessment at the Patch Application Site | Day 5-7 | 0.11 Units on a scale | Standard Deviation 0.32 |
| Flector Patch/Age 6-11 | Dermatologic Assessment at the Patch Application Site | Day 12-15 | 0.00 Units on a scale | Standard Deviation 0 |
| Flector Patch/Age 6-11 | Dermatologic Assessment at the Patch Application Site | Day1-2 | 0.10 Units on a scale | Standard Deviation 0.3 |
| Flector Patch/Age 12-16 | Dermatologic Assessment at the Patch Application Site | Day 12-15 | 0.00 Units on a scale | Standard Deviation 0 |
| Flector Patch/Age 12-16 | Dermatologic Assessment at the Patch Application Site | Day1-2 | 0.04 Units on a scale | Standard Deviation 0.19 |
| Flector Patch/Age 12-16 | Dermatologic Assessment at the Patch Application Site | Day 3-4 | 0.06 Units on a scale | Standard Deviation 0.24 |
| Flector Patch/Age 12-16 | Dermatologic Assessment at the Patch Application Site | Day 5-7 | 0.00 Units on a scale | Standard Deviation 0 |
| Flector Patch/Age 12-16 | Dermatologic Assessment at the Patch Application Site | Day 8-11 | 0.06 Units on a scale | Standard Deviation 0.24 |
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.
Time frame: Up to 2 weeks, depending upon pain resolution
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Flector Patch/Age 6-11 | Investigator Assessment of the Global Response to Therapy on a 5-point Scale | Normal function with no pain | 47 Participants |
| Flector Patch/Age 6-11 | Investigator Assessment of the Global Response to Therapy on a 5-point Scale | No clinical improvement | 1 Participants |
| Flector Patch/Age 6-11 | Investigator Assessment of the Global Response to Therapy on a 5-point Scale | Slight clinical improvement | 0 Participants |
| Flector Patch/Age 6-11 | Investigator Assessment of the Global Response to Therapy on a 5-point Scale | Moderate clinical improvement | 2 Participants |
| Flector Patch/Age 6-11 | Investigator Assessment of the Global Response to Therapy on a 5-point Scale | Marked clinical improvement | 2 Participants |
| Flector Patch/Age 12-16 | Investigator Assessment of the Global Response to Therapy on a 5-point Scale | Marked clinical improvement | 9 Participants |
| Flector Patch/Age 12-16 | Investigator Assessment of the Global Response to Therapy on a 5-point Scale | Moderate clinical improvement | 2 Participants |
| Flector Patch/Age 12-16 | Investigator Assessment of the Global Response to Therapy on a 5-point Scale | No clinical improvement | 1 Participants |
| Flector Patch/Age 12-16 | Investigator Assessment of the Global Response to Therapy on a 5-point Scale | Normal function with no pain | 40 Participants |
| Flector Patch/Age 12-16 | Investigator Assessment of the Global Response to Therapy on a 5-point Scale | Slight clinical improvement | 0 Participants |
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.
Time frame: Up to 2 weeks, depending upon pain resolution
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flector Patch/Age 6-11 | Patient Assessment of Pain on a 6-point Scale | Baseline | 3.37 units on a scale | Standard Deviation 0.56 |
| Flector Patch/Age 6-11 | Patient Assessment of Pain on a 6-point Scale | Final Visit | 0.12 units on a scale | Standard Deviation 0.47 |
| Flector Patch/Age 12-16 | Patient Assessment of Pain on a 6-point Scale | Baseline | 3.58 units on a scale | Standard Deviation 0.64 |
| Flector Patch/Age 12-16 | Patient Assessment of Pain on a 6-point Scale | Final Visit | 0.27 units on a scale | Standard Deviation 0.66 |
Secondary
Plasma Concentration of Diclofenac
Time frame: Day 2 and either Day 4, 7 or 14, depending upon pain resolution
Population: One participant missed a blood draw.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flector Patch/Age 6-11 | Plasma Concentration of Diclofenac | 24-hour | 1.83 ng/mL | Standard Deviation 2.1 |
| Flector Patch/Age 6-11 | Plasma Concentration of Diclofenac | Final Visit | 2.49 ng/mL | Standard Deviation 3.01 |
| Flector Patch/Age 12-16 | Plasma Concentration of Diclofenac | 24-hour | 1.46 ng/mL | Standard Deviation 1.88 |
| Flector Patch/Age 12-16 | Plasma Concentration of Diclofenac | Final Visit | 1.11 ng/mL | Standard Deviation 1.09 |