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

NCT04967664 | Completed Phase 3 FDA Drug

• 1 other identifier: AV001
• Study Type: interventional
• Target: 409
• Locations: 6 countries
• Sites: 64

Brief 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 to severe postsurgical neuropathic pain (PSNP).

Conditions

Post Surgical Neuropathic Pain

Outcome Measures

Primary Outcomes (2)

• Change from baseline to the weekly average score of Week 12 in the 24-hr average pain intensity [Core Phase].

  For the US. The 24-hr average pain intensity will be assessed and reported in the electronic diary (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).

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

• Change from baseline to the average score of the entire period between Week 2 and Week 12 in the 24-hr average pain intensity [Core Phase].

  For non-US countries/regions. The 24-hr average pain intensity will be assessed and reported in the electronic diary (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).

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

Secondary Outcomes (8)

• Change from baseline to Week 12 in the treatment area size [Core Phase].

  Visit 2 (Day 1) and at Visit 6 (Week 12/Day 84)

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

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

• Incidence of TEAEs leading to discontinuation [Core Phase]

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

• Change from baseline to the average score of Week 42 in the 24-hr average pain intensity [Extension Phase].

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

• Change from baseline to Week 42 in the treatment area size [Extension Phase].

  Visit 2 (Day 1) and at Visit 6 (Week 12/Day 84)

Study Arms (2)

Qutenza (capsaicin) 8% topical system

EXPERIMENTAL

Qutenza (capsaicin 8% topical system, containing capsaicin 179 mg or capsaicin 640 µg/cm2 of topical system)

Drug: Qutenza (capsaicin) 8% topical system

Low-dose capsaicin control

ACTIVE COMPARATOR

capsaicin 0.04% topical system

Drug: capsaicin 0.04% topical system

Interventions

Qutenza (capsaicin) 8% topical system DRUG

High concentration capsaicin

Qutenza (capsaicin) 8% topical system

capsaicin 0.04% topical system DRUG

Low-dose capsaicin control

Low-dose capsaicin control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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).

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Averitas Pharma, Inc.: lead

Study Sites (64)

Tucson Orthopaedic Institute

Tucson, Arizona, 85712, United States

Location

ILD Research Center

Vista, California, 92009, United States

Location

International Spine, Pain, and Performance Center

Washington D.C., District of Columbia, 20006, United States

Location

South Lake Pain Institute

Clermont, Florida, 34711, United States

Location

University Clinical Research - DeLand Clinical Research Unit

DeLand, Florida, 32720, United States

Location

Florida Research Center, Inc.

Miami, Florida, 33174, United States

Location

Clinical Research of West Florida

Tampa, Florida, 33606, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Neuroscience Research Center, LLC

Overland Park, Kansas, 66210, United States

Location

Kansas City Bone & Joint Clinic, P.A.

Overland Park, Kansas, 66211, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706, United States

Location

Premier Pain Centers

Shrewsbury, New Jersey, 07702, United States

Location

Ainsworth Institute of Pain Management

New York, New York, 10022, United States

Location

Accellacare

Wilmington, North Carolina, 28401, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

META Medical Research Institute, LLC

Dayton, Ohio, 45432, United States

Location

Main Line Spine

King of Prussia, Pennsylvania, 19406, United States

Location

New Phase Research & Development

Knoxville, Tennessee, 37909, United States

Location

Expert Pain

Houston, Texas, 77079, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Wasatch Clinical Research, LLC

Salt Lake City, Utah, 84107, United States

Location

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

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

Location

CHU de Nantes - Hopital Nord Laennec

Nantes, Pays de la Loire Region, France

Location

CHU Amiens Picardie

Amiens, France

Location

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

Angers, France

Location

Centre Hospitalier Jean Rougier

Cahors, France

Location

Centre Hospitalier Universitaire de Clermont Ferrand

Clermont-Ferrand, France

Location

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

Lille, France

Location

Clinique Francois Chenieux

Limoges, France

Location

Cochin Hospital-Paris Descartes University

Paris, France

Location

Groupe Hospitalier Paris saint-Joseph

Paris, France

Location

CHU Poitiers / La Miletrie

Poitiers, France

Location

VUMC

Amsterdam, Netherlands

Location

PT&R

Beek, Netherlands

Location

NOCEPTA

Hengelo, Netherlands

Location

Leiden University Medical Center (LUMC)

Leiden, Netherlands

Location

Centrum Medyczne Pratia Katowice

Katowice, Silesian Voivodeship, Poland

Location

Silmedic Sp z o.o. Oddzial w Katowicach

Katowice, Silesian Voivodeship, Poland

Location

Vitamed Nzoz Im. Edyty Jakubow

Bialystok, Poland

Location

Nzoz Neuro-Medic

Katowice, Poland

Location

Linden Centrum Medyczne

Krakow, Poland

Location

Instytut Zdrowia dr Boczarska-Jedynak

Oświęcim, Poland

Location

Lubelskie Centrum Diagnostyczne

Świdnik, Poland

Location

Centrum Badan Medycznych Nigrir

Warsaw, Poland

Location

FutureMeds sp. z o. o.

Wroclaw, Poland

Location

Hospital General Universitario de Alicante

Alicante, Alicante, Spain

Location

Hospital Universitario de La Princesa

Madrid, Madrid, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, Valencia, Spain

Location

Hospital Del Mar

Barcelona, Spain

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Spain

Location

Hospital Universitario La Moraleja

Madrid, Spain

Location

Hospital Quironsalud Malaga

Málaga, Spain

Location

Clinica Universidad de Navarra

Pamplona, Spain

Location

Clinica Gaias

Santiago de Compostela, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, Spain

Location

Accellacare - (MeDiNova Limited) - Northamptonshire

Corby, Northamptonshire, United Kingdom

Location

Accellacare - (MeDiNova Limited) - Yorkshire

Shipley, Yorkshire, United Kingdom

Location

Aberdeen Royal Infirmary (ARI) - NHS Grampian

Aberdeen, United Kingdom

Location

Accellacare

Coventry, United Kingdom

Location

Leeds General Infirmary - Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

Accellacare - (MeDiNova Limited) - North London

Northwood, United Kingdom

Location

MeDiNova South London Quality Research Site

Sidcup, United Kingdom

Location

MeSH Terms

Interventions

Capsaicin; Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: July 19, 2021
• Study Start: July 13, 2021
• Primary Completion: August 28, 2025
• Study Completion: August 28, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

ES (10); FR (11); GB (7); NL (4); PL (9); US (23)