The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain in comparison to placebo plaster.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
444
Change from baseline of recorded average pain intensity values during the last 24 hours, averaged over the 7 days of Week 12 of the Double-blind Treatment Period.
Time frame: Days 78-85
Mean pain intensity based on the average pain intensity during the last 24 hours, calculated over the last 4 weeks and 12 weeks of the Double blind Treatment Period.
Time frame: up to 12 weeks
Mean pain intensity based on the current pain intensity before plaster removal, calculated over the last 7 days, 4 weeks, and 12 weeks of the Double blind Treatment Period.
Time frame: up to 12 weeks
Weekly mean pain intensity before plaster removal based on the average pain intensity during the last 24 hours.
Time frame: up to 12 weeks
Weekly mean pain intensity before plaster removal based on current pain intensity before plaster removal.
Time frame: up to 12 weeks
Final score of the painDETECT Pain Questionnaire during the Double blind Treatment Period.
Time frame: Day 85
Pain intensity from mechanical dynamic allodynia (brush) testing.
Time frame: Day 85
Anxiety and depression scores of HADS.
Time frame: Day 85
The weighted Health Status Index of quality of life by means of EQ 5D.
Time frame: Day 85
Total score in quality of sleep using CPSI.
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AUT004
Klagenfurt, Austria
AUT005
Senftenberg, Austria
AUT001
Vienna, Austria
AUT006
Vienna, Austria
AUT002
Vienna, Austria
AUT003
Vienna, Austria
BEL001
Gozée, Belgium
BEL006
Halen, Belgium
BEL004
Ham, Belgium
BEL007
Lanaken, Belgium
...and 32 more locations
Time frame: Day 85
Mean pain intensity change from baseline based on the average pain intensity during the last 24 hours, calculated over the last 4 weeks and 12 weeks of the Double blind Treatment Period.
Time frame: up to 12 weeks
Mean pain intensity change from baseline based on the current pain intensity before plaster removal, calculated over the last 7 days, 4 weeks, and 12 weeks of the Double blind Treatment Period.
Time frame: up to 12 weeks
Weekly mean pain intensity change from baseline before plaster removal based on the average pain intensity during the last 24 hours.
Time frame: up to 12 weeks
Weekly mean pain intensity change from baseline before plaster removal based on current pain intensity before plaster removal.
Time frame: up to 12 weeks
Change from baseline in the total score of the painDETECT Pain Questionnaire during the Double blind Treatment Period.
Time frame: Day 85
Change from baseline in pain intensity from mechanical dynamic allodynia (brush) testing.
Time frame: Day 85
Change from baseline in anxiety and depression scores of HADS.
Time frame: Day 85
Change from baseline in total score of quality of life by means of EQ 5D.
Time frame: Day 85
Change from baseline in total score in quality of sleep using CPSI.
Time frame: Day 85