Capsaicin in digital osteoarthritis versus control : a randomized study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Hospital Of Clermont-Ferrand

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

14 Feb 2025 → ongoing

Decision date (initial)

2024-05-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

DGOS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Compare the effectiveness at 8 weeks (W8) of the transdermal application of capsaicin 8% to that of a control (low dose capsaicin at 0.04%) on finger pain, in patients with painful digital osteoarthritis with a neuropathic pain component.

Secondary objectives 4

1. Compare the effectiveness at W8 of the transdermal application of capsaicin 8% to that of capsaicin 0.04% on:  functional disability;  quality of life;  anxiety and depression;  the number of arthralgias and clinical synovitis;  the intensity of the pain concerning the most painful finger;  disease activity according to the patient;  the percentage of improvement in pain in the most painful finger;  the “Patient Global Impression of Change” (PGIC) global improvement score;  painful symptoms of osteoarthritis;  the level of ultrasensitive C-reactive protein (CRPus);  the value of inflammatory and cartilage degradation biomarkers;  consumption of analgesics and anti-inflammatories.
2. Evaluate the tolerance of the treatment.
3. To study the effect of transdermal application of capsaicin 8% on the weekly evolution of pain compared to transdermal application of capsaicin 0.04%.
4. Compare the effectiveness at 16 weeks (W16) of two transdermal applications of capsaicin 8% (eight weeks apart) to a single transdermal application of capsaicin 8% on finger pain

Conditions and MedDRA coding

digital osteoarthritis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. age greater than or equal to 18 years
2. diagnosis of digital osteoarthritis according to the criteria of the American College of Rheumatology
3. presence of finger pain of intensity ≥ 40 mm on a VAS;
4. presence of finger pain with a neuropathic painful component (DN4 score ≥ 4/10
5. inadequate response, adverse effects and/or contraindication to traditional analgesics and NSAIDs;
6. able to read and understand study information
7. signed informed consent
8. affiliation to a social security scheme.
9. Women of childbearing age must use effective contraception (pill, contraceptive implant, IUD, condoms or tubal ligation) for the entire duration of the trial

Exclusion criteria 12

1. patient with isolated rhizarthrosis
2. patient with another joint disease affecting the fingers (gout, chondrocalcinosis, RA, spondyloarthritis, psoriatic arthritis);  patient with upper limb pain syndrome which could interfere with the assessment of finger pain
3. patient with another pathology responsible for neuropathic hand pain (carpal tunnel syndrome, diabetic neuropathy, Guyon's canal syndrome, cervico-brachial neuralgia, brachial plexitis)
4. patient with skin lesions on the fingers (psoriasis, wounds, chronic ulcers, eczema, shingles, dermatitis)
5. patient with poorly controlled arterial hypertension
6. patient with hypersensitivity to capsaicin
7. patient having had an 8% capsaicin patch applied in the year before the study
8. patient having received intramuscular, intra-articular or intravenous corticosteroid therapy, another basic anti-rheumatic treatment (methotrexate, salazopyrine) or an intra-articular injection into the finger joints in the previous three months
9. patient wearing wrist or finger orthoses in the previous month
10. patient with fibromyalgia according to the opinion of the investigating doctor;
11. pregnant or breastfeeding woman; (a urine pregnancy test will be carried out in women of childbearing age before any transdermal patch placement)
12. patient under guardianship or curatorship or deprived of liberty.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Finger pain intensity at eight weeks (W8) measured on a VAS ranging from 0 to 100 mm.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Hospital Of Clermont-Ferrand

Sponsor organisation

University Hospital Of Clermont-Ferrand

Address

58 Rue Montalembert

City

Clermont Ferrand Cedex 1

Postcode

63003

Country

France

Scientific contact point

Organisation

University Hospital Of Clermont-Ferrand

Contact name

Lise Laclautre

Public contact point

Organisation

University Hospital Of Clermont-Ferrand

Contact name

Lise Laclautre

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications