The treatment regimen for the lidocaine patch 5 percent in the study involved applying the patch to the intact portion of the painful skin area (without blisters) at 12-hour intervals, twice daily, for two consecutive days. The patch was used alongside other analgesic regimens without dose adjustments, and no more than four patches were applied at a time, changed every 24 hours. The study demonstrated good tolerability with mostly mild-to-moderate adverse events and no serious adverse effects or drug interactions reported.
Key Points Explained:
-
Application Details:
- The lidocaine patch 5 percent was applied to intact skin (avoiding blistered areas).
- Frequency: Every 12 hours (twice daily).
- Duration: 2 consecutive days.
- Maximum of 4 patches applied at once, changed every 24 hours.
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Study Design:
- Open-label, non-randomized, prospective trial.
- Conducted across 7 U.S. clinical sites.
- Patients maintained their existing analgesic regimens without dosage changes.
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Safety and Tolerability:
- Adverse events were mild-to-moderate (e.g., headache, dermatitis, taste disturbance).
- No serious adverse events or clinically significant changes in vital signs/lab values.
- Well-tolerated in combination with other pain medications.
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Patient Population:
- Targeted individuals with moderate-to-severe chronic pain (PHN, painful DN, or LBP).
- Focused on areas of maximal pain for patch application.
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Outcomes:
- Effective in reducing pain intensity across multiple pain qualities.
- Demonstrated consistent tolerability with low incidence of side effects.
This regimen highlights the patch's role as a supplementary therapy for localized pain management, offering a balance of efficacy and safety.
Summary Table:
| Aspect | Details |
|---|---|
| Application | Applied to intact skin (avoiding blisters), twice daily (every 12 hours). |
| Duration | 2 consecutive days. |
| Max Patches | Up to 4 patches at once, changed every 24 hours. |
| Study Design | Open-label, non-randomized trial across 7 U.S. sites. |
| Safety Profile | Mild-to-moderate side effects (e.g., headache, dermatitis). No serious AEs. |
| Patient Population | Chronic pain (PHN, DN, LBP) with moderate-to-severe symptoms. |
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