Comparison of Qutenza (8% Capsaicin) With a Low-dose Capsaicin for Treatment of Nerve Pain After Surgery
NCT ID: NCT04967664
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
409 participants
INTERVENTIONAL
2021-07-13
2025-08-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Qutenza (capsaicin) 8% topical system
Qutenza (capsaicin 8% topical system, containing capsaicin 179 mg or capsaicin 640 µg/cm2 of topical system)
Qutenza (capsaicin) 8% topical system
High concentration capsaicin
Low-dose capsaicin control
capsaicin 0.04% topical system
capsaicin 0.04% topical system
Low-dose capsaicin control
Interventions
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Qutenza (capsaicin) 8% topical system
High concentration capsaicin
capsaicin 0.04% topical system
Low-dose capsaicin control
Eligibility Criteria
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Inclusion Criteria
1. The subject has given written informed consent to participate.
2. Female or male subjects aged 18 years or older.
3. 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
4. Documented diagnosis of PSNP by the following criteria:
1. 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.
2. Douleur Neuropathique 4 interview (DN4i) of at least 3 out of 7 points at Visit 1.
3. The pain must extend beyond the scar area to neuroanatomically adjacent skin areas and be related to the site of the surgery.
5. Documented diagnosis of probable or definite PSNP according to the following criteria (Finnerup et al. 2016):
1. 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
2. In addition to 5a : Direct surgical evidence (e.g., surgeon´s clear verification of an intraoperative nerve lesion) (criterion for definite neuropathic pain).
6. 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
7. The size of the affected painful intact skin area is not larger than the size of 4 standard Qutenza topical systems (1120 cm2).
8. 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
9. The subject is willing to adhere to the restricted use of concomitant treatments .
10. The subject experiencing pain is:
1. currently not receiving treatment for PSNP or
2. 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
Exclusion Criteria
1. 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
1. 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.
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.
2. 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
3. The subject reported a 24-hr average pain intensity score of 10 on the NPRS for at least 4 days during the Baseline Phase.
4. Any painful procedure planned during the course of the trial that may, in the opinion of the investigator, affect the efficacy or safety assessments.
5. 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.
6. 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
7. Neuropathic pain areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes.
8. 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
9. Pending litigation due to chronic pain or disability.
10. 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.
11. 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.
12. 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.
13. 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.
14. 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.
15. 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.
16. Known or suspected of not being able to comply with the requirements of the trial protocol or the instructions of the trial site staff.
17. Not able to communicate meaningfully with the trial site staff.
18. 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.
18 Years
ALL
No
Sponsors
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Averitas Pharma, Inc.
INDUSTRY
Responsible Party
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Locations
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Tucson Orthopaedic Institute
Tucson, Arizona, United States
ILD Research Center
Vista, California, United States
International Spine, Pain, and Performance Center
Washington D.C., District of Columbia, United States
South Lake Pain Institute
Clermont, Florida, United States
University Clinical Research - DeLand Clinical Research Unit
DeLand, Florida, United States
Florida Research Center, Inc.
Miami, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Drug Studies America
Marietta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Neuroscience Research Center, LLC
Overland Park, Kansas, United States
Kansas City Bone & Joint Clinic, P.A.
Overland Park, Kansas, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
Premier Pain Centers
Shrewsbury, New Jersey, United States
Ainsworth Institute of Pain Management
New York, New York, United States
Accellacare
Wilmington, North Carolina, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
META Medical Research Institute, LLC
Dayton, Ohio, United States
Main Line Spine
King of Prussia, Pennsylvania, United States
New Phase Research & Development
Knoxville, Tennessee, United States
Expert Pain
Houston, Texas, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States
Centre Hospitalier Departemental Vendee - Centre d'evaluation et de Traitement de la Douleur
La Roche-sur-Yon, Pays de la Loire Region, France
CHU de Nantes - Hopital Nord Laennec
Nantes, Pays de la Loire Region, France
CHU Amiens Picardie
Amiens, , France
Centre Regional De Lutte Contre Le Cancer (Crlcc) -Centre Paul Papin
Angers, , France
Centre Hospitalier Jean Rougier
Cahors, , France
Centre Hospitalier Universitaire de Clermont Ferrand
Clermont-Ferrand, , France
Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Claude Huriez
Lille, , France
Clinique Francois Chenieux
Limoges, , France
Cochin Hospital-Paris Descartes University
Paris, , France
Groupe Hospitalier Paris saint-Joseph
Paris, , France
CHU Poitiers / La Miletrie
Poitiers, , France
VUMC
Amsterdam, , Netherlands
PT&R
Beek, , Netherlands
NOCEPTA
Hengelo, , Netherlands
Leiden University Medical Center (LUMC)
Leiden, , Netherlands
Centrum Medyczne Pratia Katowice
Katowice, Silesian Voivodeship, Poland
Silmedic Sp z o.o. Oddzial w Katowicach
Katowice, Silesian Voivodeship, Poland
Vitamed Nzoz Im. Edyty Jakubow
Bialystok, , Poland
Nzoz Neuro-Medic
Katowice, , Poland
Linden Centrum Medyczne
Krakow, , Poland
Instytut Zdrowia dr Boczarska-Jedynak
Oświęcim, , Poland
Lubelskie Centrum Diagnostyczne
Świdnik, , Poland
Centrum Badan Medycznych Nigrir
Warsaw, , Poland
FutureMeds sp. z o. o.
Wroclaw, , Poland
Hospital General Universitario de Alicante
Alicante, Alicante, Spain
Hospital Universitario de La Princesa
Madrid, Madrid, Spain
Hospital Clinico Universitario de Valencia
Valencia, Valencia, Spain
Hospital Del Mar
Barcelona, , Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, , Spain
Hospital Universitario La Moraleja
Madrid, , Spain
Hospital Quironsalud Malaga
Málaga, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Clinica Gaias
Santiago de Compostela, , Spain
Hospital Clinico Universitario de Valladolid
Valladolid, , Spain
Accellacare - (MeDiNova Limited) - Northamptonshire
Corby, Northamptonshire, United Kingdom
Accellacare - (MeDiNova Limited) - Yorkshire
Shipley, Yorkshire, United Kingdom
Aberdeen Royal Infirmary (ARI) - NHS Grampian
Aberdeen, , United Kingdom
Accellacare
Coventry, , United Kingdom
Leeds General Infirmary - Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Accellacare - (MeDiNova Limited) - North London
Northwood, , United Kingdom
MeDiNova South London Quality Research Site
Sidcup, , United Kingdom
Countries
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Other Identifiers
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AV001
Identifier Type: -
Identifier Source: org_study_id
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