Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
NCT01054820
ABOUT THIS STUDY
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Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
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
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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain | |||
| Official Title ICMJE | Multicenter, Open-Label Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain | |||
| 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 Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Acute Back Strain | |||
| Intervention ICMJE | Drug: 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. | |||
| Study Arms ICMJE | Experimental: FLECTORA Patch (diclofenac epolamine topical patch) 1.3%
One patch applied every 12 hours Intervention: Drug: FLECTOR® Patch (diclofenac epolamine topical patch) 1.3% | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 123 | |||
| Original Estimated Enrollment ICMJE | 100 | |||
| Actual Study Completion Date ICMJE | March 2010 | |||
| Actual Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria: Participants in the study must:
Exclusion Criteria: Participants may not be in the study if they:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | United States | |||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01054820 | |||
| Other Study ID Numbers ICMJE | K353-09-4001 B4811001 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | July 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||