This study investigated the efficacy of the Lido-Patch (lidocaine 5% medicated plaster) in treatment of pain caused by PHN which is a neuropathic pain syndrome (nerve-related pain conditions) following an acute attack of herpes zoster (shingles).
Participants were treated up to 10 weeks in this study: an 8-week Run-in Phase of open-label treatment with Lido-Patch was followed by a 2-day to 14-day Double-blind Phase with Lido-Patch or Placebo Patch treatment. Only participants responding to open-label treatment with Lido-Patch were included in the Double-blind Phase. In a Follow-up Phase without treatment, the safety of participants was monitored for 1-2 weeks. Alternatively, patch application could be continued for up to 12 months in the clinical study KF10004/02.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
265
Time-to-exit in Double-blind Phase Due to Lack of Efficacy
The time to exit was defined as the number of days after randomization where worsening of the pain relief score by 2 or more categories on a 6-item pain relief scale (verbal rating scale, VRS) on 2 consecutive days in comparison to the average pain relief in Week 8 of the Run-in Phase was reported. The average pain relief in Week 8 of the enrichment phase was to be stated by the participant at the randomization visit. The VRS comprised the categories 1 = worse, 2 = no pain relief, 3 = slight, 4 = moderate, 5 = a lot, 6 = complete.
Time frame: From Day 1 until time to exit in Double-blind Phase (maximum Day 14)
Daily Pain Intensity: NRS
Pain intensity was assessed as "pain right now" directly before patch application and before patch removal, and as "24-hour average pain" before patch removal using an 11-point Numeric Rating Scale (NRS from 0 = no pain to 10 = pain as bad as you can imagine).
Time frame: From screening visit (Week -1) to end of Double-blind Phase visit (Week 10)
Daily Pain Relief
Pain relief was defined as relief at the time point directly before patch removal in comparison to the time point directly before patch application. Pain relief was assessed using a 6-item relief scale (VRS) with categories 1 = worse, 2 = no pain relief, 3 = slight, 4 = moderate, 5 = a lot, and 6 = complete.
Time frame: From screening visit (Week -1) to end of Double-blind Phase visit (Week 10)
Weekly Average 24-hour Pain Intensity: NRS
The weekly average of the 24-hour average pain intensity was calculated based on corresponding daily pain intensities over the last week before the respective visit. Pain intensities were assessed using an 11-point Numeric Rating Scale (NRS from 0 = no pain to 10 = pain as bad as you can imagine).
Time frame: During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase)
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Weekly Average Current Pain Intensity: NRS
The weekly average of the current pain ("pain right now") intensities before patch application or before patch removal were calculated based on corresponding daily pain intensities over the last week before the respective visit. Pain intensities were assessed using an 11-point Numeric Rating Scale (NRS from 0 = no pain to 10 = pain as bad as you can imagine).
Time frame: During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase)
Weekly Average Pain Relief: VRS
The weekly average pain relief was calculated based on daily pain relief over the last week before visit. Pain relief was assessed using a 6-item relief scale (VRS) with categories 1 = worse, 2 = no pain relief, 3 = slight, 4 = moderate, 5 = a lot, and 6 = complete.
Time frame: During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-bind Phase)
Weekly Worst Pain Intensity: NRS
Weekly worst pain intensity was assessed in the last week before the visit using an 11-point NRS (from 0 = no pain to 10 = pain as bad as you can imagine).
Time frame: During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase)
Weekly Average Pain Intensity: NRS
Weekly average pain intensity was assessed in the last week before the visit using an 11-point NRS (from 0 = no pain to 10 = pain as bad as you can imagine).
Time frame: During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase)
Weekly Least Pain Intensity: NRS
Weekly least pain intensity was assessed in the last week before the respective visit using an 11-point NRS (from 0 = no pain to 10 = pain as bad as you can imagine).
Time frame: During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase)