Capsaicin in Digital Osteoarthritis Versus Control : a Randomized Study

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of digital osteoarthritis fulfilling the American College of Rheumatology criteria;

• Presence of finger pain of ≥ 40 mm on a visual analogue scale (VAS);

• Presence of finger pain with a neuropathic pain component (DN4 score ≥ 4/10)

• Inadequate response, adverse reactions, and/or contraindications to conventional analgesics and NSAIDs;

Locations
Other Locations
France
CHU de Clermont-Ferrand
RECRUITING
Clermont-ferrand
HCL Hôpital Edouard Herriot
RECRUITING
Lyon
AP-HP Hôpital Saint-Antoine
RECRUITING
Paris
CHU de Saint-Etienne
RECRUITING
Saint-etienne
Contact Information
Primary
Lise Laclautre
promo_interne_drci@chu-clermontferrand.fr
334.73.754.963
Time Frame
Start Date: 2025-03-07
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 120
Treatments
Experimental: Capsaicin 8%
patch 179 mg, 30 min
Sham_comparator: Capsaicin 0.04%
patch low dose, 30 min
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Clermont-Ferrand
Collaborators: Grünenthal GmbH

This content was sourced from clinicaltrials.gov