Comparison of Qutenza vs capsaicin in post surgical nerve pain
Research type
Research Study
Full 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
IRAS ID
297318
Contact name
Patrice Forget
Contact email
Sponsor organisation
Averitas Pharma, Inc.
Eudract number
2021-001409-64
Clinicaltrials.gov Identifier
IND number: , 063354
Duration of Study in the UK
2 years, 4 months, 17 days
Research summary
This is an interventional, Phase III, double-blind, randomised, controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of repeated topical application of Qutenza (capsaicin 8% patch) versus low-dose capsaicin control (capsaicin 0.04% patch) in patients with moderate to severe Post Surgical Neuropathic Pain.
Chronic post-surgical pain is a problem worldwide. It is often overlooked or minimised, poorly treated (Schug et al. 2019), causes disability, and is associated with reduced quality of life and increased use of health care resources.
After a Screening Period of up to 12 days, including the Baseline Phase for 7 days before the Randomisation Visit participant will be allocated to Qutenza or to low-dose capsaicin control patch (capsaicin 0.04%). 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.Participants remain on the treatment allocated at Randomisation and are offered the identical IMP in the double-blinded Extension Phase.
This is a multi centre study being conducted in the UK, USA and some other non-US countries. Each participant is expected to be in the trial for up to 44 weeks.
REC name
London - Westminster Research Ethics Committee
REC reference
21/LO/0679
Date of REC Opinion
26 Nov 2021
REC opinion
Further Information Favourable Opinion