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.
Lay summary of study results:
Qutenza is a patch that is applied to the painful area on the skin and helps reduce localised pain in the treatment area. It contains high concentration of capsaicin, which is released into the skin from the patch where it blocks pain signaling.This trial looked at how well Qutenza works (efficacy) at reducing post-surgical neuropathic pain. Post-surgical neuropathic pain is a type of chronic pain that is caused by damage to the nerves due to surgery. It typically presents in a defined localised area of the body, usually related to the surgery location.
Participants were randomly divided into 2 groups and received a 60-minute application of either Qutenza patch or control patch.
The researchers wanted to know:
- Does Qutenza reduce pain better than control over 12 weeks?
Researchers also wanted to know:
- Does Qutenza reduce pain better than control in the long term (over 42 weeks)?
- Does it reduce the size of the painful area better than control?
- What medical problems, if any, did participants experience during the trial and did they lead to trial discontinuation?Participants were randomly assigned to receive either Qutenza or control patches to their most painful area of the skin, where the treatment was applied for 60 minutes. The trial was divided into a screening period, a Core Phase treatment period and an Extension Phase treatment period.
Efficacy: Did Qutenza reduce pain better than control?
To answer this question, participants were asked to rate their average pain from 0 (no pain at all) to 10 (pain as bad as you can imagine) every day. At the end of the trial, researchers took the weekly averages of these scores and looked at how these average pain scores compared with baseline (the average pain score within the last 7 days before first treatment). Researchers calculated this in 2 ways:
• First way was to compare the participants’ pain scores at Week 12 and at Week 42 to their pain scores within the week before the first treatment (baseline).
• Second way was to compare the participants’ average pain scores between Week 2 and Week 12 as well as between Week 2 and Week 42 to their pain scores at baseline.Researchers found that when they look at pain scores the second way, participants in the Qutenza group had significantly less pain by Week 12 and Week 42 compared to participants in the control group.
When calculating in the first way however, participants in both the Qutenza and the control group had less pain without significant difference between the two groups.
The painful area also reduced in both groups by Week 12 and Week 42 without significant difference between the two groups.
Safety: What medical problems did participants have?
During the trial, some participants may have experienced medical problems for any reason, whether related to the trial treatments (Qutenza or control) or not.
• More participants in the Qutenza group had temporary medical problems: 63.6% in the Qutenza group and 55.5% of participants in the control group. Most of these were application site reactions (such as pain where the patch was applied on the skin).
• Ten participants dropped out of the trial due to a medical problem (8 in the Qutenza group and 2 in the control group). Six of these discontinuations were considered related to the trial treatment (five application site reactions in the Qutenza group and one allergic reaction in the control group).
• No unusual results were found in vital signs (such as blood pressure and heart rate), or skin assessments.
Overall, no new safety concerns were identified in this trial and Qutenza was considered well- tolerated with no increased risk after multiple treatments.What serious medical problems did participants experience?
• Serious medical problems are those that may cause disability, lasting problems, life-threatening conditions, hospitalisation, or death.
• No deaths occurred during this trial.
• 14 participants in the Qutenza group and 8 participants in the control group had a serious medical problem, but only one, in the control group, was considered possibly related to the treatment (none were considered related to the treatment in the Qutenza group).How was this trial useful for patients and researchers?
• This clinical trial showed that a single, 60-minute application of Qutenza can reduce pain better than control over a period of 12 weeks in patients with post- surgical neuropathic pain.
• It also showed that up to 5 Qutenza treatments can reduce pain better than control over a longer period of 42 weeks.
• While more participants receiving Qutenza experienced a medical problem compared to control, these were mostly non-serious short-term application site reactions; no new safety concerns and no increased risk with repeated treatments were identified.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