Not an actual patient.
Evaluating the preference and willingness for reapplication treatments for painful DPN of the feet1
Phase 3, 52-week, multinational, open-label, randomized, controlled safety study of QUTENZA, conducted in Europe.
Patients were randomized to receive 30-minute treatments of QUTENZA + SOC, or SOC alone, to assess the safety of repeat treatment with QUTENZA in patients with painful DPN of the feet.
Patients in the QUTENZA study arms could receive repeated treatments, at the investigator’s discretion, no more frequently than every eight weeks, up to a total of seven treatments over the 52 weeks of the study.
In the US, treatment with QUTENZA may be repeated every three months or as warranted by the return of pain (not more frequently than every three months).
SOC/rescue medications – antidepressants, antiepileptics and/or opioids – were optimized for each patient in each study arm, at the investigator’s discretion.
Rescue medications were for pain associated with topical system treatments and used on days 1 to 5 after topical system treatment only.
SOC was used in painful DPN of the feet at the discretion of the investigator and optimized for patients on an individual basis.