The proportion of patients in each arm who achieved optimal therapeutic effect (OTE) was assessed. OTE was defined as: no change in background chronic pain medication (assessed by an Independent Data Review Board); no discontinuation of the study drug due to lack of efficacy or tolerability prior to Week 8; ≥30% reduction in the NPRS score over at least 4 consecutive days from baseline to Week 8; and no moderate or severe adverse drug reactions (ADRs) during the stable treatment period. For the capsaicin patch, the stable treatment period equated to weeks 1–8 of the treatment period. It excluded the first week of treatment to avoid confounding factors associated with the use of short‐acting oral analgesics during this period, and to allow for the onset of action of the capsaicin patch. For pregabalin the stable treatment period equated to the period over which the subject was dosed at the optimal maintenance dose, and was different for each subject.
Time‐to‐onset of pain relief (in days) as assessed by ≥30% reduction in the NPRS score. The median time‐to‐onset of pain relief was the first of 3 consecutive days where 50% of patients had a ≥30% reduction in NPRS score versus baseline.
Change from baseline NPRS for the past 24 h was assessed by the proportion of patients who achieved ≥30% and ≥50% decrease in the NPRS score from baseline to the mean of all scores recorded between Week 2 and Week 8, respectively; as well as the absolute and per cent change.
Pre‐specified analyses of the primary endpoint were performed according to patient subgroups based on patient age (<65, ≥65, <75 years), gender, time since diagnosis (<6 months, ≥6 months to ≤1 year, >1 year to ≤2 years, >2 years to ≤10 years, >10 years), maximum Neuropathic Pain Symptom Inventory (NPSI) subscales [burning (superficial) spontaneous pain, pressing (deep) spontaneous pain, paroxymal pain, evoked pain, paraesthesia/dysaesthesia], type of pain (PHN, PNI, non‐diabetic painful peripheral polyneuropathy), pain grading (probable neuropathic pain, definite neuropathic pain), baseline pain score (<7, ≥7) and previous use of pregabalin/gabapentin.
Treatment satisfaction, as assessed by the proportion of patients who discontinued study drug or withdrew from the study due to either a lack of efficacy or tolerability; willingness to continue treatment at Week 8; and the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire at Week 4 and Week 8, with statistical comparisons of TSQM scores adjusted for country group and gender.
Other patient rated outcomes were assessed (EQ‐5D‐5L, Patient Global Impression of Change, Medical Outcomes Study 6‐Item Cognitive Functioning and Sleep) and will be reported separately.
Safety analyses were conducted on all patients who received study drug. A treatment‐emergent adverse event (TEAE) was defined as an AE that started or increased in severity after intake/application of the study drug. An ADR was defined as an AE with probable or possible relationship with the study drug.
Time‐to‐onset of pain relief (in days) as assessed by ≥30% reduction in the NPRS score. The median time‐to‐onset of pain relief was the first of 3 consecutive days where 50% of patients had a ≥30% reduction in NPRS score versus baseline.
Change from baseline NPRS for the past 24 h was assessed by the proportion of patients who achieved ≥30% and ≥50% decrease in the NPRS score from baseline to the mean of all scores recorded between Week 2 and Week 8, respectively; as well as the absolute and per cent change.
Pre‐specified analyses of the primary endpoint were performed according to patient subgroups based on patient age (<65, ≥65, <75 years), gender, time since diagnosis (<6 months, ≥6 months to ≤1 year, >1 year to ≤2 years, >2 years to ≤10 years, >10 years), maximum Neuropathic Pain Symptom Inventory (NPSI) subscales [burning (superficial) spontaneous pain, pressing (deep) spontaneous pain, paroxymal pain, evoked pain, paraesthesia/dysaesthesia], type of pain (PHN, PNI, non‐diabetic painful peripheral polyneuropathy), pain grading (probable neuropathic pain, definite neuropathic pain), baseline pain score (<7, ≥7) and previous use of pregabalin/gabapentin.
Treatment satisfaction, as assessed by the proportion of patients who discontinued study drug or withdrew from the study due to either a lack of efficacy or tolerability; willingness to continue treatment at Week 8; and the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire at Week 4 and Week 8, with statistical comparisons of TSQM scores adjusted for country group and gender.
Other patient rated outcomes were assessed (EQ‐5D‐5L, Patient Global Impression of Change, Medical Outcomes Study 6‐Item Cognitive Functioning and Sleep) and will be reported separately.
Safety analyses were conducted on all patients who received study drug. A treatment‐emergent adverse event (TEAE) was defined as an AE that started or increased in severity after intake/application of the study drug. An ADR was defined as an AE with probable or possible relationship with the study drug.
