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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01054820
First received: January 20, 2010
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Acute Back Strain
Drug: FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Open-Label Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain

Resource links provided by NLM:


Further study details as provided by Pfizer:

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 [ Time Frame: Baseline, End of Treatment (last visit up to Day 15) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, End of Treatment (last visit up to Day 15) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, End of Treatment (last visit up to Day 15) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, End of Treatment (last visit up to Day 15) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, End of Treatment (last visit up to Day 15) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, End of Treatment (last visit up to Day 15) ] [ Designated as safety issue: No ]
    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 [ Time Frame: End of Treatment (up to Day 15) ] [ Designated as safety issue: No ]
    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 [ Time Frame: End of Treatment (up to Day 15) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, End of Treatment (last visit up to Day 15) ] [ Designated as safety issue: No ]
    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 [ Time Frame: End of Treatment (last visit up to Day 15) ] [ Designated as safety issue: No ]
    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 [ Time Frame: End of Treatment (last visit up to Day 15) ] [ Designated as safety issue: No ]
    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.


Enrollment: 123
Study Start Date: January 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FLECTORA Patch (diclofenac epolamine topical patch) 1.3%
One patch applied every 12 hours
Drug: FLECTOR® 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054820

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01054820     History of Changes
Other Study ID Numbers: K353-09-4001, B4811001
Study First Received: January 20, 2010
Results First Received: July 10, 2012
Last Updated: July 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
FLECTOR® Patch
acute back strain

Additional relevant MeSH terms:
Sprains and Strains
Wounds and Injuries
Diclofenac
Diclofenac hydroxyethylpyrrolidine
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014