Acute Back StrainPhase 4NCT01054820
Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
A Phase 4 study testing FLECTOR® Patch (diclofenac epolamine topical patch) 1.3% in people with Acute Back Strain, run by Pfizer.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Back Strain
- What is being tested?
- FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Mar 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Multicenter, Open-Label Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
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.
- Conditions
- Acute Back Strain
- Being tested
- FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%
- Keywords
- FLECTOR® Patch, acute back strain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%Drug
One FLECTOR Patch applied to the most painful area on the subject's back every 12 hours for up to 14 days.
| Study group | Role | What they receive |
|---|---|---|
| FLECTORA Patch (diclofenac epolamine topical patch) 1.3% | Experimental | One patch applied every 12 hours Receives: Drug: FLECTOR® Patch (diclofenac epolamine topical patch) 1.3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, End of Treatment (last visit up to Day 15)
Secondary outcomes (10)
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of Treatment (last visit up to Day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Back StrainStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054820
- Sponsor's protocol ID
- K353-09-4001
- Other IDs
- B4811001
- Status last verified
- Jul 2012
- First submitted
- 20 Jan 2010
- Last updated
- 16 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-Label Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
- ClinicalTrials.gov ID
- NCT01054820
- Acronym / sponsor ID
- K353-09-4001
- Conditions
- Acute Back Strain
- Keywords
- FLECTOR® Patch, acute back strain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 22 Jan 2010 (estimated)
- Results
- Posted 16 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLECTORA Patch (diclofenac epolamine topical patch) 1.3% | Experimental | Drug: FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%One patch applied every 12 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | FLECTORA Patch (diclofenac epolamine topical patch) 1.3% |
Primary outcome
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)
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).
10 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
Mean Change From Baseline to EOT in Beck Depression Inventory® Il
Time frame: 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
Time frame: 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
Time frame: End of Treatment (last visit up to Day 15)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FLECTOR® Patch (diclofenac epolamine topical patch) 1.3% in people with Acute Back Strain, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2012.