Acute Back Strain
Conditions
Keywords
FLECTOR® Patch, acute back strain
Brief summary
Although approved for minor strains, sprains and contusions, FLECTOR Patch has not been studied extensively in the setting of acute back strain. This study is being conducted as an initial step in demonstrating the benefit of FLECTOR Patch specifically for back strain. In particular, this study is expected to provide information about the amount of improvement in back strain among subjects using the FLECTOR Patch, which may then be used to inform subsequent studies.
Interventions
DRUGFLECTOR® Patch (diclofenac epolamine topical patch) 1.3%
One FLECTOR Patch applied to the most painful area on the subject's back every 12 hours for up to 14 days.
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants in the study must: 1. have acute, non-radicular back strain with onset up to 10 days before the first visit 2. have intact, non-damaged skin at the proposed patch application site 3. be untreated or unresponsive to conservative pain treatment regimens and/or opioids 4. have a minimum pain intensity score of four (4) or more on a scale of 1-10 (a rating of zero (0) being no pain and a rating of ten (10) being pain as bad as you can imagine) 5. have a normal neurologic examination
Exclusion criteria
Participants may not be in the study if they: 1. have had surgery or other chronic pain condition within 3 months before first treatment 2. have back pain radiating below the knee at time of enrollment 3. have neuropathic pain or have been treated with gabapentin or pregabalin for neuropathy 4. are being treated for or are known to currently have kidney or liver disease 5. have certain other diseases or are using certain types of other drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to End of Treatment (EOT) in Response to Modified Brief Pain Inventory (mBPI) Question 5: Average Pain Over the Last 24 Hours | Baseline, End of Treatment (last visit up to Day 15) | Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 5: Please rate your pain by marking the box beside the number that best describes your pain on the average (over the last 24 hours); rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 3: Pain at Its Worst in the Last 24 Hours | Baseline, End of Treatment (last visit up to Day 15) | Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 3: Rate your pain at its worst in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). |
| Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 4: Pain at Its Least in the Last 24 Hours | Baseline, End of Treatment (last visit up to Day 15) | Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 4: Rate your pain at its least in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). |
| Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 6: Pain Right Now | Baseline, End of Treatment (last visit up to Day 15) | Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 6: Rate your pain right now; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). |
| Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 8: Percent Reduction in Pain From Baseline | Baseline, End of Treatment (last visit up to Day 15) | Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 8: Rate your percent reduction in pain from Baseline (0% = no relief to 100% = complete relief). |
| Number of Participants With Change From Baseline (Bsl) to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 1: Pain Other Than Everyday Kind of Pain | Baseline, End of Treatment (last visit up to Day 15) | Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 1: Have you had pain other than everyday kinds of pain?; response = Yes or No. |
| Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator | End of Treatment (up to Day 15) | Participants' global pain relief as assessed by investigator using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change. |
| Mean Change From Baseline to EOT in Beck Depression Inventory® Il | Baseline, End of Treatment (last visit up to Day 15) | The Beck Depression Inventory® II consisted of 21 items, each with 4 categorical responses ranging from 0 (I do not feel sad) to 3 (I am so sad or unhappy that I can't stand it) with maximum possible score of 63; increase in the number reflected an increase in severity. Total Beck Depression Inventory® II scores classified as follows: 1 to 10=normal ups and downs; 11 to 16=mild mood disturbance; 17 to 20=borderline clinical depression; 21 to 30=moderate depression; 31 to 40=severe depression; and \>40=extreme depression. |
| Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant | End of Treatment (last visit up to Day 15) | Participant satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied. |
| Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator | End of Treatment (last visit up to Day 15) | Investigator's assessment of participants' satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied. |
| Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant | End of Treatment (up to Day 15) | Global pain relief as assessed by participant using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible. | 123 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. |
|---|---|
| Age Continuous | 38.8 years STANDARD_DEVIATION 12.4 |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 123 |
| serious Total, serious adverse events | 1 / 123 |
Outcome results
Primary
Mean Change From Baseline to End of Treatment (EOT) in Response to Modified Brief Pain Inventory (mBPI) Question 5: Average Pain Over the Last 24 Hours
Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 5: Please rate your pain by marking the box beside the number that best describes your pain on the average (over the last 24 hours); rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Time frame: Baseline, End of Treatment (last visit up to Day 15)
Population: Intent to Treat (ITT) population: had at least one application of FLECTOR® Patch, pain survey data at Baseline, and at least 1 follow-up visit. EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Mean Change From Baseline to End of Treatment (EOT) in Response to Modified Brief Pain Inventory (mBPI) Question 5: Average Pain Over the Last 24 Hours | Baseline | 6.46 scores on a scale | Standard Deviation 1.3 |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Mean Change From Baseline to End of Treatment (EOT) in Response to Modified Brief Pain Inventory (mBPI) Question 5: Average Pain Over the Last 24 Hours | Change from baseline to EOT | -3.95 scores on a scale | Standard Deviation 2.51 |
Comparison: Null hypothesis: no change from baseline. Study powered at 95 percent (%) to detect a mean change of at least 1.2 units, with assumed standard deviation of at most 3.2 units.p-value: <0.0001t-test, 2 sided
Secondary
Mean Change From Baseline to EOT in Beck Depression Inventory® Il
The Beck Depression Inventory® II consisted of 21 items, each with 4 categorical responses ranging from 0 (I do not feel sad) to 3 (I am so sad or unhappy that I can't stand it) with maximum possible score of 63; increase in the number reflected an increase in severity. Total Beck Depression Inventory® II scores classified as follows: 1 to 10=normal ups and downs; 11 to 16=mild mood disturbance; 17 to 20=borderline clinical depression; 21 to 30=moderate depression; 31 to 40=severe depression; and \>40=extreme depression.
Time frame: Baseline, End of Treatment (last visit up to Day 15)
Population: ITT population; End-of-Treatment score was the most recent non-missing value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Mean Change From Baseline to EOT in Beck Depression Inventory® Il | Baseline | 3.44 scores on a scale | Standard Deviation 5.47 |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Mean Change From Baseline to EOT in Beck Depression Inventory® Il | Change from baseline to EOT | -1.54 scores on a scale | Standard Deviation 3.05 |
p-value: <0.0001t-test, 2 sided
Secondary
Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 3: Pain at Its Worst in the Last 24 Hours
Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 3: Rate your pain at its worst in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Time frame: Baseline, End of Treatment (last visit up to Day 15)
Population: ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 3: Pain at Its Worst in the Last 24 Hours | Baseline | 7.59 scores on a scale | Standard Deviation 1.19 |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 3: Pain at Its Worst in the Last 24 Hours | Change from baseline to EOT | -4.50 scores on a scale | Standard Deviation 2.48 |
p-value: <0.0001t-test, 2 sided
Secondary
Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 4: Pain at Its Least in the Last 24 Hours
Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 4: Rate your pain at its least in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Time frame: Baseline, End of Treatment (last visit up to Day 15)
Population: ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 4: Pain at Its Least in the Last 24 Hours | Baseline | 5.46 scores on a scale | Standard Deviation 1.84 |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 4: Pain at Its Least in the Last 24 Hours | Change from baseline to EOT | -3.50 scores on a scale | Standard Deviation 2.3 |
p-value: <0.0001t-test, 2 sided
Secondary
Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 6: Pain Right Now
Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 6: Rate your pain right now; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Time frame: Baseline, End of Treatment (last visit up to Day 15)
Population: ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 6: Pain Right Now | Baseline | 6.49 scores on a scale | Standard Deviation 1.76 |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 6: Pain Right Now | Change from baseline to EOT | -4.28 scores on a scale | Standard Deviation 2.28 |
p-value: <0.0001t-test, 2 sided
Secondary
Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 8: Percent Reduction in Pain From Baseline
Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 8: Rate your percent reduction in pain from Baseline (0% = no relief to 100% = complete relief).
Time frame: Baseline, End of Treatment (last visit up to Day 15)
Population: ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day. N=number of participants with analyzable data for Question 8 at observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 8: Percent Reduction in Pain From Baseline | Baseline | 2.94 percent | Standard Deviation 11.23 |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 8: Percent Reduction in Pain From Baseline | Change from baseline to EOT | 67.30 percent | Standard Deviation 30.58 |
p-value: <0.0001t-test, 2 sided
Secondary
Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator
Participants' global pain relief as assessed by investigator using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change.
Time frame: End of Treatment (up to Day 15)
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator | 3=Moderate Improvement | 8 participants |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator | 2=Slight Improvement | 10 participants |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator | 5=Complete Relief | 58 participants |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator | 4=A Lot Of Improvement | 42 participants |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator | 1=No Change | 5 participants |
Secondary
Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant
Global pain relief as assessed by participant using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change.
Time frame: End of Treatment (up to Day 15)
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant | 5=Complete Relief | 53 participants |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant | 4=A Lot Of Improvement | 42 participants |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant | 3=Moderate Improvement | 12 participants |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant | 2=Slight Improvement | 12 participants |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant | 1=No Change | 4 participants |
Secondary
Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant
Participant satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied.
Time frame: End of Treatment (last visit up to Day 15)
Population: ITT; End-of-Treatment score for patch satisfaction consisted of the last value recorded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant | 5=Very Satisfied | 63 participants |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant | 4=Satisfied | 45 participants |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant | 3=No Preference | 6 participants |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant | 2=Dissatisfied | 8 participants |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant | 1=Very Dissatisfied | 1 participants |
Secondary
Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator
Investigator's assessment of participants' satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied.
Time frame: End of Treatment (last visit up to Day 15)
Population: ITT; End-of-Treatment score for patch satisfaction consisted of the last value recorded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator | 5=Very Satisfied | 66 participants |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator | 4=Satisfied | 39 participants |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator | 3=No Preference | 9 participants |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator | 2=Dissatisfied | 8 participants |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator | 1=Very Dissatisfied | 1 participants |
Secondary
Number of Participants With Change From Baseline (Bsl) to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 1: Pain Other Than Everyday Kind of Pain
Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 1: Have you had pain other than everyday kinds of pain?; response = Yes or No.
Time frame: Baseline, End of Treatment (last visit up to Day 15)
Population: ITT population; EOT score was the last non-missing score obtained on a treatment day, including the final treatment visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants With Change From Baseline (Bsl) to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 1: Pain Other Than Everyday Kind of Pain | Change at EOT: Bsl=Yes, EOT=Yes | 93 participants |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants With Change From Baseline (Bsl) to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 1: Pain Other Than Everyday Kind of Pain | Change at EOT: Bsl=Yes, EOT=No | 21 participants |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants With Change From Baseline (Bsl) to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 1: Pain Other Than Everyday Kind of Pain | Change at EOT: Bsl=No, EOT=Yes | 0 participants |
| FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%. | Number of Participants With Change From Baseline (Bsl) to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 1: Pain Other Than Everyday Kind of Pain | Change at EOT: Bsl=No, EOT=No | 9 participants |
p-value: <0.0001McNemar