Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter, Open-Label Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain

Conditions
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Acute Back Strain

Intervention / Treatment
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* Drug: FLECTORÂ® Patch (diclofenac epolamine topical patch) 1.3%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants in the study must: have acute, non-radicular back strain with onset up to 10 days before the first visit have intact, non-damaged skin at the proposed patch application site be untreated or unresponsive to conservative pain treatment regimens and/or opioids 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) have a normal neurologic examination Exclusion Criteria: Participants may not be in the study if they: have had surgery or other chronic pain condition within 3 months before first treatment have back pain radiating below the knee at time of enrollment have neuropathic pain or have been treated with gabapentin or pregabalin for neuropathy are being treated for or are known to currently have kidney or liver disease have certain other diseases or are using certain types of other drugs.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLECTORA Patch (diclofenac epolamine topical patch) 1.3%<br>One patch applied every 12 hours | Drug: FLECTORÂ® Patch (diclofenac epolamine topical patch) 1.3%<br>* One FLECTOR Patch applied to the most painful area on the subject's back every 12 hours for up to 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline, End of Treatment (last visit up to Day 15) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, End of Treatment (last visit up to Day 15) | 
| 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). | Baseline, End of Treatment (last visit up to Day 15) | 
| 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). | Baseline, End of Treatment (last visit up to Day 15) | 
| 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). | Baseline, End of Treatment (last visit up to Day 15) | 
| 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). | Baseline, End of Treatment (last visit up to Day 15) | 
| 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. | End of Treatment (up to Day 15) | 
| 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. | End of Treatment (up to Day 15) | 
| 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. | Baseline, End of Treatment (last visit up to Day 15) | 
| 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. | End of Treatment (last visit up to Day 15) | 
| 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. | End of Treatment (last visit up to Day 15) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FLECTORÂ® Patch, acute back strain