Phase 4
N=123
Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
Acute Back Strain
Bottom Line
View on ClinicalTrials.gov: NCT01054820 ↗Enrolled (actual)
123
Serious AEs
0.8%
Results posted
Aug 2012
Primary outcome: Primary: 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 — 6.46; -3.95 scores on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- FLECTOR® Patch (diclofenac epolamine topical patch) 1.3% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
6.46; -3.95 | <0.0001 sig |
| SECONDARY 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 |
93; 21; 0; 9 | <0.0001 sig |
| SECONDARY 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 |
7.59; -4.50 | <0.0001 sig |
| SECONDARY 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 |
5.46; -3.50 | <0.0001 sig |
| SECONDARY Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 6: Pain Right Now |
6.49; -4.28 | <0.0001 sig |
| SECONDARY Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 8: Percent Reduction in Pain From Baseline |
2.94; 67.30 | <0.0001 sig |
| SECONDARY Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant |
53; 42; 12; 12; 4 | — |
| SECONDARY Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator |
58; 42; 8; 10; 5 | — |
| SECONDARY Mean Change From Baseline to EOT in Beck Depression Inventory® Il |
3.44; -1.54 | <0.0001 sig |
| SECONDARY Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant |
63; 45; 6; 8; 1 | — |
| SECONDARY Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator |
66; 39; 9; 8; 1 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01054820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.