Study on Capsaicin for Treating Post-Surgical Neuropathic Pain in Patients

3 1 1 1

What is this study about?

This clinical trial is focused on studying a condition known as post-surgical neuropathic pain, which is a type of pain that some people experience after surgery. The study is evaluating the effectiveness and safety of a treatment called Qutenza, which is a patch applied to the skin. The active ingredient in Qutenza is capsaicin, a substance that is often used to relieve pain. The trial aims to see if Qutenza can better reduce pain compared to a low-dose capsaicin patch.

Participants in the study will be randomly assigned to receive either the Qutenza patch or a low-dose capsaicin patch. The study will last for several weeks, during which participants will have their pain levels monitored regularly. The main goal is to observe changes in pain intensity from the start of the study to the end of the 12-week period. The study will also look at any side effects that may occur during the treatment.

The trial is designed to help understand how well Qutenza works in reducing pain and to ensure it is safe for use. Participants will be closely monitored throughout the study to gather information on how the treatment affects their pain and overall health. This research is important for developing better treatments for people who suffer from post-surgical neuropathic pain.

1 initial visit

The initial visit involves a comprehensive assessment to confirm eligibility for the trial. This includes a review of medical history and a physical examination.

A pregnancy test is conducted for women of childbearing potential. Consent forms are signed to confirm understanding and agreement to participate.

2 baseline phase

During the baseline phase, pain levels are recorded daily using an electronic diary. This phase lasts for seven days.

The average pain intensity is calculated from these recordings to establish a baseline for comparison during the trial.

3 randomization visit

At the randomization visit, participants are randomly assigned to receive either the Qutenza patch or a low-dose capsaicin control.

The Qutenza patch contains 179 mg of capsaicin and is applied to the skin. The application is performed by a healthcare professional.

4 treatment phase

The treatment phase involves the application of the Qutenza patch. The patch is applied to the affected area of the skin for a specified duration.

The treatment is repeated as necessary, with intervals determined by the healthcare team based on individual response and trial protocol.

5 follow-up visits

Follow-up visits are scheduled to monitor progress and assess any side effects. Pain levels are continuously recorded and evaluated.

The primary goal is to observe changes in pain intensity from the baseline to Week 12. Additional assessments may occur up to Week 42.

6 end of trial

At the end of the trial, a final evaluation is conducted to assess the overall effectiveness and safety of the treatment.

Participants may discuss their experience and any ongoing treatment needs with the healthcare team.

Who Can Join the Study?

The person must have given written permission to join the study.
The person experiencing pain is either not currently receiving treatment for post-surgical neuropathic pain or is on a stable treatment that started more than 30 days before the second visit.
The person must be 18 years old or older, regardless of gender.
Women who can have children must have negative pregnancy tests at specific visits and agree to use reliable birth control methods.
The person must have a confirmed diagnosis of post-surgical neuropathic pain with pain lasting between 6 to 60 months, related to surgery, and extending beyond the scar area.
The person must have a confirmed or likely diagnosis of post-surgical neuropathic pain with pain linked to sensory changes in the same area, or direct surgical evidence of nerve damage.
The person must have moderate to severe pain, with an average pain score of at least 4 out of 10, based on daily pain ratings over a week.
The painful skin area should not be larger than the size of four standard Qutenza patches (1120 cm²).
The skin where the treatment will be applied must be intact, dry, and not irritated, with no signs of skin disease or injury.
The person must agree to follow restrictions on using other treatments during the study.

Who Cannot Join the Study?

Patients who have a different type of pain that is not related to surgery.
Patients who are currently participating in another clinical trial.
Patients who have a known allergy to capsaicin, which is a substance found in chili peppers.
Patients who have a skin condition that could interfere with the study treatment.
Patients who are pregnant or breastfeeding.
Patients who have a medical condition that the study doctors believe could make it unsafe for them to participate.
Patients who are unable to follow the study procedures or instructions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Neuro-Medic Sp. z o.o.	Katowice	Poland
Centre Hospitalier Universitaire De Lille	Lille	France
Futuremeds Sp. z o.o.	Wroclaw	Poland
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hospital Del Mar	Barcelona	Spain
Silmedic Sp. z o.o.	Katowice	Poland
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Ziekenhuisgroep Twente Stichting	Almelo	The Netherlands
Linden Sp. z o.o. sp.k.	Cracow	Poland
Centre Hospitalier Jean Rougier	Cahors	France
Hospital Quironsalud Malaga	Malaga	Spain
Polyclinique De Limoges	Limoges	France
Pratia S.A.	Skorzewo	Poland
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Tomasz Blicharski Lubelskie Centrum Diagnostyczne	Swidnik	Poland
Hopital Beaujon	Clichy	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Lfvyx Uuxasohsaajf Mhgtpcz Cojcgjf (mblzv	Leiden	The Netherlands
Hppjigdk Upczxummtariu Dz Lz Pmpefrhe	Madrid	Spain
Vewvyfg Sdc z obed	Bialystok	Poland
Ngdeauct Ivumqemj Ghftmxdkt Rzoiaklgcana I Rigmgwqcslflv Id Pnrwg Ds Haka Mlxw Erewzhud Rpqjjbm	Warsaw	Poland
Gpwqid Hsrxstkhalh Ubxalxgdcljge Pxfst Pplechlwqqf Ew Nwbgnnkedfom	Paris	France
Ibbiofml Zrjdpae Db Bwqxxybjybalmmmam	Oświęcim	Poland

Trial status

Country	Status	Recruitment Start
France	Not recruiting	16.11.2021
Poland	Not recruiting	16.11.2021
Spain	Not recruiting	16.11.2021
The Netherlands	Not recruiting	16.11.2021

Trial locations

Investigated drugs:

Capsaicin

Qutenza is a medication used in this clinical trial to help manage post-surgical neuropathic pain. It is a patch that contains capsaicin, which is a substance found in chili peppers. The patch is applied to the skin, and it works by reducing the amount of pain signals sent to the brain, helping to relieve pain in the affected area. The trial aims to show that Qutenza is more effective than a low-dose capsaicin control in reducing pain intensity over a 12-week period.

Post-surgical neuropathic pain – This condition occurs when nerves are damaged during surgery, leading to persistent pain in the area where the surgery was performed. The pain is often described as burning, shooting, or stabbing and can be accompanied by sensations of tingling or numbness. It typically begins shortly after the surgical procedure and can persist for weeks, months, or even longer. The intensity of the pain can vary, and it may be constant or intermittent. Over time, the pain may either improve or remain a chronic issue, affecting the individual’s quality of life.

Trial ID:

2024-514934-19-00

Protocol code:

AV001

NCT ID:

NCT04967664

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Capsaicin for Treating Post-Surgical Neuropathic Pain in Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?