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Post Surgical Neuropathic PainPhase 3RISENCT04967664

Comparison of Qutenza (8% Capsaicin) With a Low-dose Capsaicin for Treatment of Nerve Pain After Surgery

A Phase 3 study testing Qutenza (capsaicin) 8% topical system and capsaicin 0.04% topical system in people with Post Surgical Neuropathic Pain, run by Averitas Pharma, Inc. at 64 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post Surgical Neuropathic Pain
What is being tested?
Qutenza (capsaicin) 8% topical system and capsaicin 0.04% topical system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
412 participants
Where
64 sitesin 6 countries
Study dates
13 Jul 2021to 28 Aug 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General
  • The subject has given written informed consent to participate.
  • Female or male subjects aged 18 years or older.
  • For women of childbearing potential: negative pregnancy tests at Screening Visit (Visit 1), the Randomization Visit (Visit 2), and prior to each reapplication of the investigational medicinal product (IMP), and must have agreed to practice medically acceptable methods of birth control.
  • Confirmation of diagnosis of chronic moderate to severe PSNP
  • Documented diagnosis of PSNP by the following criteria:
Show all 23Show fewer
  • A history of post-surgical pain with a duration of at least 6 months to maximally 60 months that is plausibly related to the surgical intervention as documented on a body map.
  • Douleur Neuropathique 4 interview (DN4i) of at least 3 out of 7 points at Visit 1.
  • The pain must extend beyond the scar area to neuroanatomically adjacent skin areas and be related to the site of the surgery.
  • Documented diagnosis of probable or definite PSNP according to the following criteria (Finnerup et al. 2016):
  • The pain must be associated with sensory signs in the same neuroanatomically plausible distribution. The area of sensory changes may extend beyond, be within, or overlap with the area of pain (criterion for probable neuropathic pain), or
  • In addition to 5a : Direct surgical evidence (e.g., surgeon´s clear verification of an intraoperative nerve lesion) (criterion for definite neuropathic pain).
  • The subject has moderate to severe pain with a baseline value for 24-hr average pain intensity of at least 4 points on the NPRS. The baseline value is calculated as the average of the 24-hr average pain intensity ratings of the Baseline Phase (Day -7 to Day -1). At least 5 (out of the last 7 days) pain ratings should be available during the Baseline Phase. If less than 5 pain ratings are available in the last 7 days, the subject may be rescheduled for Visit 2 (1 time only) after having received appropriate re-training in the use of the e-diary to ensure compliance.
  • Suitability for treatment with IMP
  • The size of the affected painful intact skin area is not larger than the size of 4 standard Qutenza topical systems (1120 cm2).
  • The skin in the area where the IMP will be applied, and that may also contain the scar tissue, is intact, dry, and non-irritated (i.e., there are no signs and symptoms of skin disease, skin irritation, inflammation or injury, such as active herpes zoster lesions, atopic dermatitis, ulceration, wounds). This is reflected by a dermal assessment score of 0 = "no evidence of irritation" or 1 = "minimal erythema, barely perceptible".
  • Eligibility with regard to protocol adherence, to allowed pre-treatments and concomitant treatments
  • The subject is willing to adhere to the restricted use of concomitant treatments .
  • The subject experiencing pain is:
  • currently not receiving treatment for PSNP or
  • receives a stable systemic treatment for PSNP that started more than 30 days prior to the Randomization Visit (Visit 2).
  • Non-exhaustive list of examples of types of surgeries with resulting PSNP:
  • Thoracic surgery Breast surgery Abdominal surgery (cholecystectomy, appendectomy) Donor nephrectomy Gynecologic surgery (hysterectomy, C-section) Varicose vein surgery Inguinal herniotomy Lipoma removal Knee surgery Knee arthroplasty Ankle surgery

Who cannot join

  • General or previous treatments
  • The subject received Qutenza before the Randomization Visit (Visit 2) or received a medical device in another clinical trial within 7 days before the Randomization Visit (Visit 2), or
  • Any former use of topical capsaicin in the area of the PSNP before Visit 2, except for the use of a low-dose (<1%) capsaicin product - but not within 7 days before Visit 2.
  • The subject participated previously in this clinical trial or participated in another clinical trial for the treatment of PSNP completing less than 3 months ago.
  • A score of 0 out of 5 in all 3 categories of the neurological/sensory examinations, i.e., for warm sensation, pinprick and cold sensation at the Screening Visit (Visit 1).
  • Confounding factors
Show all 25Show fewer
  • The subject reported a 24-hr average pain intensity score of 10 on the NPRS for at least 4 days during the Baseline Phase.
  • Any painful procedure planned during the course of the trial that may, in the opinion of the investigator, affect the efficacy or safety assessments.
  • Subjects with PSNP related to a surgery/condition with a high potential for confounding symptoms, e.g., the pain is at least partially due to pain in deeper structures such as muscles or bones (including referred pain from deeper structures) as listed in examples.
  • Other painful conditions in the body area that is affected by PSNP and may affect efficacy or safety assessments and cannot be discriminated from the target pain by the subject, including infectious, non-infectious, inflammatory or neuropathic conditions which could also be complications related to the previous surgical procedure.
  • Non-exhaustive list of examples of types of surgeries/conditions not suitable for eligibility Any surgery performed due to suspected neoplasia: suspected residual neoplasia or metastases Conditions where nociceptive or neuropathic pain has been the reason for the surgery, e.g., failed back surgery, carpal tunnel syndrome or other nerve compression syndromes leading to neuropathic pain, (e.g., meralgia paresthetica) Conditions of projected neuropathic pain (i.e., from inguinal hernia repair) with painful symptoms in the genital region, e.g., the scrotum or vagina Amputations Radicular pain and nerve trunk lesions Scar pain neuroma Complex Regional Pain Syndrome (Type I or Type II)
  • Contraindications to IMP
  • Neuropathic pain areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes.
  • Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter [OTC] capsaicin products), or to any excipients of the IMP or to excipients of the cleansing gel in use and their components, or to topical anesthetics in use and their components.
  • Medical history/concurrent condition(s)/other factors
  • Pending litigation due to chronic pain or disability.
  • The subject has a history of alcohol or drug abuse or is actively abusing drugs (including alcohol, medication) during the 1 year prior to the Screening Visit (Visit 1) as judged by the investigator.
  • Evidence or history of severe psychiatric illness/disorder during the 3 years prior to the Screening Visit (Visit 1) that, in the investigator's opinion, may affect efficacy or safety assessments or may compromise the subject's safety during trial participation, e.g., major depression, major anxiety disorder, psychosis, severe personality disorders.
  • Evidence of cognitive impairment including dementia that may interfere with the subject's ability to complete pain assessments requiring recall of the average pain level in the past 24 hrs.
  • Surgical intervention in the last 3 months preceding the Screening Visit (Visit 1) if it is affecting the efficacy or safety assessments, or any scheduled or planned surgery during the trial, with the exception of the Extension Phase if the planned surgery is not expected to affect the efficacy or safety assessments.
  • Patients with current clinically significant disease(s) or condition(s) (including clinically significant cardiovascular disease and/or significant pain in other areas) that may affect efficacy or safety assessments, or any other reason which, in the investigator's opinion, may preclude the subject's participation in the full duration of the trial. Patients with current signs and symptoms consistent with Coronavirus disease 2019 (COVID-19) (e.g., dry cough, dyspnea, sore throat, fatigue, fever) or patients who had those symptoms within the last 14 days prior to screening and had a positive SARS-CoV2 PCR test result.
  • Unstable or poorly controlled blood pressure which, in the opinion of the investigator, would put the subject at risk of severe adverse blood pressure increases upon IMP application.
  • Known or suspected of not being able to comply with the requirements of the trial protocol or the instructions of the trial site staff.
  • Not able to communicate meaningfully with the trial site staff.
  • The subject is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site, or is a family member of the employees or the investigator.

Trial locations and contacts

64 sites in 6 countries.

64 sites in 6 countries

United States23 sites

  • Great Lakes Research Group, Inc.

    Bay City, Michigan, 48706

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • South Lake Pain Institute

    Clermont, Florida, 34711

  • META Medical Research Institute, LLC

    Dayton, Ohio, 45432

  • University Clinical Research - DeLand Clinical Research Unit

    DeLand, Florida, 32720

  • Expert Pain

    Houston, Texas, 77079

  • Main Line Spine

    King of Prussia, Pennsylvania, 19406

  • New Phase Research & Development

    Knoxville, Tennessee, 37909

  • Drug Studies America

    Marietta, Georgia, 30060

  • Florida Research Center, Inc.

    Miami, Florida, 33174

  • Ainsworth Institute of Pain Management

    New York, New York, 10022

  • Neuroscience Research Center, LLC

    Overland Park, Kansas, 66210

  • Kansas City Bone & Joint Clinic, P.A.

    Overland Park, Kansas, 66211

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah, 84107

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Premier Pain Centers

    Shrewsbury, New Jersey, 07702

  • Clinical Research of West Florida

    Tampa, Florida, 33606

  • Tucson Orthopaedic Institute

    Tucson, Arizona, 85712

  • ILD Research Center

    Vista, California, 92009

  • International Spine, Pain, and Performance Center

    Washington D.C., District of Columbia, 20006

  • Accellacare

    Wilmington, North Carolina, 28401

  • The Center for Clinical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

France11 sites

  • CHU Amiens Picardie

    Amiens

  • Centre Regional De Lutte Contre Le Cancer (Crlcc) -Centre Paul Papin

    Angers

  • Centre Hospitalier Jean Rougier

    Cahors

  • Centre Hospitalier Universitaire de Clermont Ferrand

    Clermont-Ferrand

  • Centre Hospitalier Departemental Vendee - Centre d'evaluation et de Traitement de la Douleur

    La Roche-sur-Yon, Pays de la Loire Region

  • Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Claude Huriez

    Lille

  • Clinique Francois Chenieux

    Limoges

  • CHU de Nantes - Hopital Nord Laennec

    Nantes, Pays de la Loire Region

  • Cochin Hospital-Paris Descartes University

    Paris

  • Groupe Hospitalier Paris saint-Joseph

    Paris

  • CHU Poitiers / La Miletrie

    Poitiers

Other trials in France

Spain10 sites

  • Hospital General Universitario de Alicante

    Alicante

  • Hospital Del Mar

    Barcelona

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat

  • Hospital Universitario de La Princesa

    Madrid

  • Hospital Universitario La Moraleja

    Madrid

  • Hospital Quironsalud Malaga

    Málaga

  • Clinica Universidad de Navarra

    Pamplona

  • Clinica Gaias

    Santiago de Compostela

  • Hospital Clinico Universitario de Valencia

    Valencia

  • Hospital Clinico Universitario de Valladolid

    Valladolid

Other trials in Spain

Poland9 sites

  • Vitamed Nzoz Im. Edyty Jakubow

    Bialystok

  • Centrum Medyczne Pratia Katowice

    Katowice, Silesian Voivodeship

  • Silmedic Sp z o.o. Oddzial w Katowicach

    Katowice, Silesian Voivodeship

  • Nzoz Neuro-Medic

    Katowice

  • Linden Centrum Medyczne

    Krakow

  • Instytut Zdrowia dr Boczarska-Jedynak

    Oświęcim

  • Lubelskie Centrum Diagnostyczne

    Świdnik

  • Centrum Badan Medycznych Nigrir

    Warsaw

  • FutureMeds sp. z o. o.

    Wroclaw

Other trials in Poland

United Kingdom7 sites

  • Aberdeen Royal Infirmary (ARI) - NHS Grampian

    Aberdeen

  • Accellacare - (MeDiNova Limited) - Northamptonshire

    Corby, Northamptonshire

  • Accellacare

    Coventry

  • Leeds General Infirmary - Leeds Teaching Hospitals NHS Trust

    Leeds

  • Accellacare - (MeDiNova Limited) - North London

    Northwood

  • Accellacare - (MeDiNova Limited) - Yorkshire

    Shipley, Yorkshire

  • MeDiNova South London Quality Research Site

    Sidcup

Other trials in United Kingdom

Netherlands4 sites

  • VUMC

    Amsterdam

  • PT&R

    Beek

  • NOCEPTA

    Hengelo

  • Leiden University Medical Center (LUMC)

    Leiden

Other trials in Netherlands

About this study

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

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).

Read the 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

Being tested
Qutenza (capsaicin) 8% topical system, capsaicin 0.04% topical system

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Qutenza (capsaicin) 8% topical systemDrug

    High concentration capsaicin

  • capsaicin 0.04% topical systemDrug

    Low-dose capsaicin control

Study groups in NCT04967664
Study groupRoleWhat they receive
Qutenza (capsaicin) 8% topical systemExperimentalQutenza (capsaicin 8% topical system, containing capsaicin 179 mg or capsaicin 640 µg/cm2 of topical system)
Receives: Drug: Qutenza (capsaicin) 8% topical system
Low-dose capsaicin controlActive comparatorcapsaicin 0.04% topical system
Receives: Drug: capsaicin 0.04% topical system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in the 24-Hour Average Pain Intensity (API) Between Week 2 and Week 12 [Core Phase]

    NOTES:

    • For non-US regulatory authorities: Change from baseline to the average score of the entire period between Week 2 and Week 12 in the 24 h API analyzed using ANCOVA.
    • The 24 h API was assessed and reported in the e-diary once daily in the evening, using an 11 point numeric pain rating scale NPRS] (from 0 = no pain to 10 = pain as bad as you can imagine).
    • The outcome was the change from baseline to the average score over the entire period between Week 2 and Week 12. A negative change indicates a reduction in pain.

    Measured: From the Baseline Phase (Day -7 to Day -1) to Visit 6 (Week 12/Day 84).

  2. Change From Baseline in the 24-Hour API to Week 12 [Core Phase]

    NOTES:

    • For US regulatory authority: Change from baseline to the weekly average score of Week 12 in the 24 h API analyzed using MMRM.
    • The 24 h API was assessed and reported in the e-diary once daily in the evening, using an 11 point numeric pain rating scale NPRS] (from 0 = no pain to 10 = pain as bad as you can imagine).
    • The outcome was the change from baseline to the weekly average score at Week 12. A negative change indicates a reduction in pain.

    Measured: From the Baseline Phase (Day -7 to Day -1) to Visit 6 (Week 12/Day 84).

Secondary outcomes (8)

  1. Change From Baseline in the 24-Hour API Between Week 2 and Week 42 [Extension Phase]

    NOTES:

    • For non-US regulatory authorities: Change from baseline to the average score of the entire period between Weeks 2-42 in the 24 h API.
    • The 24 h API was assessed and reported in the e-diary once daily in the evening, using an 11 point numeric pain rating scale NPRS] (from 0 = no pain to 10 = pain as bad as you can imagine).
    • The outcome was the change from baseline to the average score over the entire period between Week 2 and Week 42. A negative change indicates a reduction in pain.

    Measured: Baseline Phase (Day -7 to Day -1) up to the Final Visit (Week 42/Day 294).

  2. Change From Baseline in the 24-Hour API at Week 42 [Extension Phase]

    NOTES:

    • For US regulatory authority: Change from baseline to the weekly average score of Week 42 in the 24 h API analyzed using ANCOVA..
    • The 24 h API was assessed and reported in the e-diary once daily in the evening, using an 11 point numeric pain rating scale NPRS] (from 0 = no pain to 10 = pain as bad as you can imagine).
    • The outcome was the change from baseline to the weekly average score at Week 42. A negative change indicates a reduction in pain.

    Measured: Baseline Phase (Day -7 to Day -1) up to the Final Visit (Week 42/Day 294).

  3. Change From Baseline in Treatment Area Size at Week 12 [Core Phase]

    Treatment area size was measured in square centimeters (cm²) and comprised the area identified by the participant as the usually most painful area(s), and/or the area characterized by dynamic mechanical allodynia (DMA), and/or the area of pinprick hyperalgesia. Treatment area size was assessed at Visit 2 (Day 1) before IMP application and at Visit 6 (Week 12/Day 84) before IMP application. The outcome was the change from baseline to Week 12 in treatment area size. A negative change indicates a reduction in treatment area size.

    Measured: From Visit 2 (Day 1, before IMP application) to Visit 6 (Week 12/Day 84, before IMP application).

  4. Change From Baseline in Treatment Area Size at Week 42 [Extension Phase]

    Treatment area size was measured in square centimeters (cm²) and comprised the area identified by the participant as the usually most painful area(s), and/or the area characterized by dynamic mechanical allodynia (DMA), and/or the area of pinprick hyperalgesia. The outcome was the change from baseline to the Final Visit at Week 42 in treatment area size. A negative change indicates a reduction in treatment area size.

    Measured: From baseline to the Final Visit at Week 42.

  5. Incidence of Treatment-Emergent Adverse Events (TEAEs) [Core Phase]

    Documentation of TEAEs (Safety and tolerability) from the start of treatment at Visit 2 (Day 1) up to the end of the Core Phase of the Treatment Period.

    Measured: Visit 2 (Day 1) up to Visit 6 (Week 12/Day 84)

  6. Incidence of TEAEs Leading to Discontinuation From Trial [Core Phase]

    Documentation of TEAEs (Safety and tolerability) from the start of treatment at Visit 2 (Day 1) up to the end of the Core Phase of the Treatment Period.

    Measured: Visit 2 (Day 1) up to Visit 6 (Week 12/Day 84)

  7. Incidence of TEAEs [Extension Phase]

    Documentation of TEAEs (Safety and tolerability) from the start of treatment at Visit 2 (Day 1) up to the end of the Extension Phase.

    Measured: Visit 2 (Day 1) up to Final Visit (Week 42/Day 294)

  8. Incidence of TEAEs Leading to Discontinuation From Trial [Extension Phase]

    Documentation of TEAEs (Safety and tolerability) from the start of treatment at Visit 2 (Day 1) up to the end of the Extension Phase.

    Measured: Visit 2 (Day 1) up to Final Visit (Week 42/Day 294)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2021
  2. Study start13 Jul 2021
  3. Primary completion28 Aug 2025
  4. Study completion28 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04967664
Sponsor's protocol ID
AV001
Acronym
RISE
Status last verified
Aug 2026
First submitted
10 Jun 2021
Last updated
21 Sep 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Qutenza (capsaicin) 8% topical system and capsaicin 0.04% topical system in people with Post Surgical Neuropathic Pain, run by Averitas Pharma, Inc. at 64 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, France, Spain, Poland, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the 24-Hour Average Pain Intensity (API) Between Week 2 and Week 12 [Core Phase] (time frame: From the Baseline Phase (Day -7 to Day -1) to Visit 6 (Week 12/Day 84).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04967664.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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