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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 Pain

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

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

Page last updated: August 23, 2015

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