Comparison of Qutenza (8% Capsaicin) With a Low-dose Capsaicin for Treatment of Nerve Pain After Surgery
brief summary
This is an interventional, Phase III, double-blind, randomized, controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of repeated topical application of Qutenza (capsaicin 8% topical system) versus low-dose capsaicin control (capsaicin 0.04% topical system) in subjects with moderate to severe postsurgical neuropathic pain (PSNP).
detailed description
After a Screening Period of up to 19 days, including the Baseline Phase from Day -7 to Day -1, subjects will be allocated to Qutenza or to low-dose capsaicin control topical system (capsaicin 0.04%) at the Randomization Visit. The blinded Treatment Period consists of a Core Phase (Day 1 to Week 12) and an Extension Phase (Week 13 to Week 42), which includes a Follow-up of 14 days
official title
An Interventional, Phase III, Double-blind, Randomized, Controlled, Parallel-group, Multi-site, Clinical Trial Evaluating the Efficacy and Safety of Qutenza® in Subjects With Post-surgical Neuropathic Pain