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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.

Navarre headquarters
Madrid headquarters
Status
In recruitment
headquarters
Pamplona

Technical Summary

  • PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, CONTROLLED, PARALLEL-GROUP, MULTICENTER INTERVENTIONAL CLINICAL TRIAL TO CONFIRM THE EFFICACY AND SAFETY OF QUTENZA® IN PATIENTS WITH POST-SURGICAL NEUROPATHIC PAIN
  • Code EudraCT: 2021-001409-64
  • Protocol number: AV001
  • Promoter: Averitas Pharma
  • Link to Clinical Trials

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.

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