Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Back Strain
Intervention: FLECTOR® Patch (diclofenac epolamine topical patch) 1.3% (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: Multicenter, Open-Label Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Secondary outcome: 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 PainMean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 3: Pain at Its Worst in the Last 24 Hours 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 Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 6: Pain Right Now Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 8: Percent Reduction in Pain From Baseline Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator Mean Change From Baseline to EOT in Beck Depression Inventory® Il Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: January 2010
Last updated: July 10, 2012
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