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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511159-16-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Grünenthal GmbH | INDUSTRY |
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The objective of this multicentric, randomized controlled double-blind clinical trial is to demonstrate the efficacy of transdermal application of capsaicin in patients with painful digital osteoarthritis with a neuropathic pain component.
Participants will receive either a transdermal patch of capsaicin 179 mg (8%) or the control treatment (capsaicin 0.04%).
Researchers will compare the intensity of pain in the fingers at day 60 in the capsaicin 8% group versus capsaicin 0.04% (control arm)
Visit 0 : Screening visit (D0 - 30 days): Screen for eligibility
Visit 1 :Inclusion visit (D0): Randomization and blinded patch application of capsaicin 8% or 0.04%
Visit 2: Follow-up visit 1 (D60 + 7 days): Assessment +/- Patch renewal. Patients with finger pain still greater than 4/10 may receive an open application of a capsaicin 8%
Visit 3:Follow-up visit 2 (D120 +/- 7 days): Final assessment.
For the duration of the study, the patient will record in a notebook: analgesics, anti-inflammatories, corticoids and daily hand pain VAS.
Blood samples will be taken at V1 and V2 for subsequent measurement of pro-inflammatory cytokines (IL6, IL8, TNFa) and markers of cartilage degradation, in order to build up a serum library.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capsaicin 8% | Experimental | patch 179 mg, 30 min |
|
| Capsaicin 0.04% | Sham Comparator | patch low dose, 30 min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsaicin 179 Mg Cutaneous Patch | Drug | patch application for 30 minutes on the painful fingers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of pain in the fingers | measured on a visual analogic scale ranging from 0 to 100 mm | Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional disability | Cochin Hand Functional Disability Scale score, Each question is rated from 0 (no difficulty) to 5 (impossible). Total score for 18 questions: 0 - 90. The higher the score, the more impaired the physical function. | Day 60 |
| Functional index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | 334.73.754.963 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Sylvain Mathieu | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40050054 | Derived | Fan A, Lambert C, Sellam J, Chapurlat R, Marotte H, Pereira B, Thomas T, Tournadre A, Soubrier M, Mathieu S. CADOR (Capsaicin in neuropathic-like pain in digital osteoarthritis) study protocol: a multicentre randomised parallel-group trial. BMJ Open. 2025 Mar 6;15(3):e093409. doi: 10.1136/bmjopen-2024-093409. |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| D057968 | Transdermal Patch |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
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| Capsaicine low dose 0.04 % | Drug | patch application for 30 minutes on the painful fingers. the low-dose patch has a similar appearance to the active patch. It allows you to keep the blind, because it also causes reactions at the capsaicin application site (erythema, burning). |
|
|
Modified Functional Index for Hand OsteoArthritis score (FIHOA), Each question is rated from 0 (no difficulty) to 3 (impossible). Total score for the 10 questions: 0 - 30. The higher the score, the greater the functional disability. |
| Day 60 |
| Anxiety and depression | Hospital Anxiety and Depression Scale score (HADs), Each question is scored from 0 to 3. Total score for the 7 anxiety or depression questions: 0-21. The higher the score, the more anxious or depressed the patient. | Day 60 |
| Painful symptoms of osteoarthritis | Osteoarthritis Symptom Inventory Scale score (OASIS9). Localized pain component = 4 questions rated from 0 (no sensation) to 10 (extreme sensation) score = 0-40. Neuropathic pain component = 2 questions rated from 0 to 10 score = 0-20. Deep pain component = 3 questions rated from 0 to 10 score = 0-30. Total OASIS score: 0-90. A high score indicates intense pain. | Day 60 |
| Treatment safety | side effect rate | Day 60 |
| Patient impression of change | Patient Global Impression of Change " (PGIC) score. The patient evaluates the degree of improvement of his pain
| Day 60 |
| HCL Hôpital Edouard Herriot | Recruiting | Lyon | France |
|
| AP-HP Hôpital Saint-Antoine | Recruiting | Paris | France |
|
| CHU de Saint-Etienne | Recruiting | Saint-Etienne | France |
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006839 |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004864 | Equipment and Supplies |