Post-surgical neuropathic pain
Conditions
Brief summary
Change from baseline to the average score of the entire period between Week 2 and Week 12 in the 24-hr average pain intensity.
Detailed description
Change from baseline to Week 12 in the treatment area size., Incidence of treatment-emergent adverse events (TEAEs). Incidence of TEAEs leading to discontinuation in the Core Phase., Change from baseline to the weekly average score of Week 42 in the 24-hr average pain intensity., Change from baseline to Week 42 in the treatment area size., Change from baseline to the average score of the entire period between Week 2 and Week 42 in the 24-hr average pain intensity., Incidence of TEAEs. Incidence of TEAEs leading to discontinuation in the Extension Phase.
Interventions
DRUGCAPSAICIN
Sponsors
Averitas Pharma Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the average score of the entire period between Week 2 and Week 12 in the 24-hr average pain intensity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 12 in the treatment area size., Incidence of treatment-emergent adverse events (TEAEs). Incidence of TEAEs leading to discontinuation in the Core Phase., Change from baseline to the weekly average score of Week 42 in the 24-hr average pain intensity., Change from baseline to Week 42 in the treatment area size., Change from baseline to the average score of the entire period between Week 2 and Week 42 in the 24-hr average pain intensity., Incidence of TEAEs. Incidence of TEAEs leading to discontinuation in the Extension Phase. | — |
Countries
France, Netherlands, Poland, Spain
Outcome results
None listed