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

Phase 4

Completed

• Conditions: Acute Back Strain
• Interventions: Drug: FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%

• Registration Number: NCT01054820
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-22
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2012-07
• Results First Submitted: 2012-07-10
• Results First Submitted QC: 2012-07-10
• Last Update Submitted: 2012-07-10
• Results First Posted: 2012-08-16
• Last Update Posted: 2012-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FLECTORA Patch (diclofenac epolamine topical patch) 1.3%	FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%	One patch applied every 12 hours

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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 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.
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.