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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
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Back Strain focused on measuring FLECTOR® Patch, acute back strain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    January 20, 2010
    Last Updated
    July 10, 2012
    Sponsor
    Pfizer
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    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
    To obtain contact information for a study center near you, click here.

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