Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
Primary Purpose
Acute Back Strain
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%
Sponsored by
About this trial
This is an interventional treatment trial for Acute Back Strain focused on measuring FLECTOR® Patch, acute back strain
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FLECTORA Patch (diclofenac epolamine topical patch) 1.3%
Arm Description
One patch applied every 12 hours
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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).
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).
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).
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).
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01054820
Brief Title
Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
Official Title
Multicenter, Open-Label Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Back Strain
Keywords
FLECTOR® Patch, acute back strain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FLECTORA Patch (diclofenac epolamine topical patch) 1.3%
Arm Type
Experimental
Arm Description
One patch applied every 12 hours
Intervention Type
Drug
Intervention Name(s)
FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%
Intervention Description
One FLECTOR Patch applied to the most painful area on the subject's back every 12 hours for up to 14 days.
Primary Outcome Measure Information:
Title
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
Description
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)
Secondary Outcome Measure Information:
Title
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
Description
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)
Title
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
Description
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)
Title
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
Description
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)
Title
Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 6: Pain Right Now
Description
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)
Title
Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 8: Percent Reduction in Pain From Baseline
Description
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)
Title
Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant
Description
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)
Title
Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator
Description
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)
Title
Mean Change From Baseline to EOT in Beck Depression Inventory® Il
Description
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)
Title
Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant
Description
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)
Title
Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=K353-09-4001&StudyName=Study%20to%20Assess%20the%20Effectiveness%20and%20Safety%20of%20FLECTOR%20Patch%20for%20Treatment%20of%20Acute%20Back%20Strain
Description
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Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
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