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

Who is this study for? Patients with Post Surgical Neuropathic Pain
What treatments are being studied? Capsaicin
Status: Recruiting
Location: See all (65) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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).

• 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

Locations
United States
Arizona
Tucson Orthopaedic Institute
Recruiting
Tucson
California
UCSD Center for Pain Medicine
Not yet recruiting
La Jolla
ILD Research Center
Recruiting
Vista
Washington, D.c.
International Spine, Pain, and Performance Center
Recruiting
Washington
Florida
Synergy Healthcare
Recruiting
Bradenton
South Lake Pain Institute
Recruiting
Clermont
University Clinical Research - DeLand Clinical Research Unit
Recruiting
Deland
Universal Axon Clinical Research
Recruiting
Doral
Clinical Research of West Florida
Recruiting
Tampa
Georgia
Drug Studies America
Recruiting
Marietta
Idaho
Injury Care Research
Recruiting
Boise
Illinois
Millennium Pain Center
Recruiting
Bloomington
Rush University Medical Center
Not yet recruiting
Chicago
The University of Chicago Medicine
Not yet recruiting
Chicago
Kansas
University of Kansas Medical Center
Recruiting
Kansas City
Kansas City Bone & Joint Clinic, P.A.
Recruiting
Overland Park
Neuroscience Research Center, LLC
Recruiting
Overland Park
Massachusetts
Boston Clinical Trials
Recruiting
Boston
Michigan
Great Lakes Research Group, Inc.
Recruiting
Bay City
New Jersey
Premier Pain Centers
Recruiting
Shrewsbury
New Mexico
Albuquerque Neuroscience, Incorporated
Recruiting
Albuquerque
New York
Montefiore Medical Center
Recruiting
Bronx
University of Rochester Medical Center (URMC)
Not yet recruiting
Rochester
Ohio
META Medical Research Institute, LLC
Recruiting
Dayton
Tennessee
New Phase Research & Development
Recruiting
Knoxville
Texas
HD Research LLC
Recruiting
Bellaire
Cedar Health Research, LLC
Recruiting
Dallas
Expert Pain
Recruiting
Houston
Washington
Sweedish Pain Clinic
Not yet recruiting
Seattle
Other Locations
France
CHU Amiens Picardie
Recruiting
Amiens
Centre Hospitalier Jean Rougier
Recruiting
Cahors
Centre Hospitalier Departemental Vendee - Centre d'evaluation et de Traitement de la Douleur
Recruiting
La-roche-sur-yon
Clinique Francois Chenieux
Recruiting
Limoges
CHU de Nantes - Hopital Nord Laennec
Recruiting
Nantes
Cochin Hospital-Paris Descartes University
Recruiting
Paris
Groupe Hospitalier Paris saint-Joseph
Recruiting
Paris Cedex 14
CHU Poitiers / La Miletrie
Recruiting
Poitiers
Netherlands
NOCEPTA
Recruiting
Hengelo
Leiden University Medical Center (LUMC)
Recruiting
Leiden
Maxima Medisch Centrum Veldhoven
Recruiting
Veldhoven
Poland
Vitamed Nzoz Im. Edyty Jakubow
Recruiting
Białystok
Centrum Medyczne Pratia Katowice
Recruiting
Katowice
Nzoz Neuro-Medic
Recruiting
Katowice
Silmedic Sp z o.o. Oddzial w Katowicach
Recruiting
Katowice
Linden Centrum Medyczne
Recruiting
Krakow
Instytut Zdrowia dr Boczarska-Jedynak
Recruiting
Oświęcim
Lubelskie Centrum Diagnostyczne
Recruiting
Swidnik
Centrum Badan Medycznych Nigrir
Recruiting
Warszawa
FutureMeds sp. z o. o.
Recruiting
Wroclaw
Spain
Hospital General Universitario de Alicante
Recruiting
Alicante
Hospital Clinic i Provincial de Barcelona
Recruiting
Barcelona
Hospital Del Mar
Recruiting
Barcelona
Hospital Universitario de Bellvitge
Recruiting
L'hospitalet De Llobregat
Hospital Universitario de La Princesa
Recruiting
Madrid
Hospital Universitario La Moraleja
Recruiting
Madrid
Clinica Universidad de Navarra
Recruiting
Pamplona
Clinica Gaias
Recruiting
Santiago De Compostela
Hospital Clinico Universitario de Valencia
Recruiting
Valencia
Hospital Clinico Universitario de Valladolid
Recruiting
Valladolid
United Kingdom
Aberdeen Royal Infirmary (ARI) - NHS Grampian
Recruiting
Aberdeen
Accellacare - (MeDiNova Limited) - Northamptonshire
Recruiting
Corby
Accellacare
Recruiting
Coventry
Accellacare - (MeDiNova Limited) - North London
Recruiting
Northwood
Accellacare - (MeDiNova Limited) - Yorkshire
Recruiting
Shipley
MeDiNova South London Quality Research Site
Recruiting
Sidcup
Contact Information
Primary
Chris Van Damme
Chris.VanDamme-ext@averitaspharma.com
908-393-0047
Time Frame
Start Date: July 13, 2021
Estimated Completion Date: April 2024
Participants
Target number of participants: 408
Treatments
Experimental: Qutenza (capsaicin) 8% topical system
Qutenza (capsaicin 8% topical system, containing capsaicin 179 mg or capsaicin 640 µg/cm2 of topical system)
Active Comparator: Low-dose capsaicin control
capsaicin 0.04% topical system
Authors
Bruce G Rankin, Ezekiel Fink, Julio Paez, Tolga Suvar, Khalilah Weston, Ioannis Skaribas, Dean J Vayser, Sean Li, Jeffrey A Potts, Nebojsa Skrepnik, Natalie L Clarke, Marvin D Tark, Dalia Elmofty, Mark Wallace, Talal Khan, Paula J Lane, Lon D Lynn, Steven Stanos, Naum Shaparin, Mehul J Desai, Priyesh Mehta, Atul T Patel, Eliezer Soto, Mayank Gupta, Aleksandra Karbowniczek, Tomasz Blicharski, Sandrine Soriot-Thomas, Gaelle Martine Fabre, Babatunde Oyesile, Anton Poterajlo, Philippe Rigoard, Patrice Forget, Venkata Kondagunta, Slim Lassoued, Emmanuelle Bougouin-Kuhn, Paul Walukiewicz, Ronnie Beboso, Luis A Martinez, Ilona Palka-Kisielowska, Daneshvari R Solanki, Cesar Margarit Ferri, Richard Radnovich, Andres Ancor Serrano Afonso, Yves-Marie Pluchon, Armando C Villarreal, Marcin Janecki, Alejandro Orts Castro, Juan Antonio Garcia Meijide, Juan Carlos Tornero Tornero, Janusz Zbrojkiewicz, Antonio Montes Perez, Maria Concepcion Perez Hernandez, Agnieszka Kurbiel, Beata Tarnacka, Marguerite D'Ussel, Serge Perrot, Deborah Green-La Roche, Magdalena Boczarska-Jedynak, Christian Dursteler Tatxe, Sally Azeez, Piotr Jakubow, Ewa Jazwinska-Tarnawska, Motunrayo Adesanya, Enrique Ortega Ladron de Cegama, Nicolas Varela, Marieke Niesters, Rudolfus Roumen, Nelson Paulo Monteiro de Oliveira
Sponsors
Leads: Averitas Pharma, Inc.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials