Clinical trial of Qutenza® in patients with post-surgical neuropathic pain

THE OBJECTIVE OF THIS STUDY IS TO DEMONSTRATE THE SAFETY AND EFFECTIVENESS OF QUTENZA® (CAPSAICIN 8% TOPICAL APPLICATION SYSTEM) COMPARED TO CAPSAICIN 0.04% TOPICAL APPLICATION SYSTEMS IN PARTICIPANTS WITH MODERATE TO SEVERE CIPD. A TOPICAL DELIVERY SYSTEM CONSISTS OF A DRUG THAT IS APPLIED BY MEANS OF AN ADHESIVE PATCH THAT IS PLACED ON THE SKIN. THE DRUG IS ABSORBED THROUGH THE SKIN. THE STUDY ALSO EVALUATES WHETHER LONG-TERM USE OF QUTENZA® IS EFFECTIVE, SAFE AND WELL TOLERATED COMPARED TO 0.04% CAPSAICIN PATCHES. THE CAPSAICIN 8% TOPICAL DELIVERY SYSTEM HAS BEEN APPROVED TO TREAT CHRONIC NEUROPATHIC SKIN PAIN, OFTEN CAUSED BY CONDITIONS SUCH AS SHINGLES OR DIABETES. THE 0.04% CAPSAICIN TOPICAL DELIVERY SYSTEM IS USED AS AN ACTIVE PLACEBO COMPARATOR, MEANING THAT IT IS NOT EXPECTED TO HAVE A SIGNIFICANT EFFECT ON NEUROPATHIC PAIN, BUT IS EXPECTED TO CAUSE A SENSATION SIMILAR TO QUTENZA® WHEN APPLIED.