Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444919
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-31
Brief Title:
Capsaicin in Digital Osteoarthritis Versus Control
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Capsaicin in Digital Osteoarthritis Versus Control a Randomized Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CADOR
Brief 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 004
Researchers will compare the intensity of pain in the fingers at day 60 in the capsaicin 8 group versus capsaicin 004 control arm
Participants will receive either a transdermal patch of capsaicin 179 mg 8 or the control treatment capsaicin 004
Researchers will compare the intensity of pain in the fingers at day 60 in the capsaicin 8 group versus capsaicin 004 control arm
Detailed Description:
Visit 0 Screening visit D0 - 30 days Screen for eligibility
Visit 1 Inclusion visit D0 Randomization and blinded patch application of capsaicin 8 or 004
Visit 2 Follow-up visit 1 D60 7 days Assessment - Patch renewal Patients with finger pain still greater than 410 may receive an open application of a capsaicin 8
Visit 3Follow-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
Visit 1 Inclusion visit D0 Randomization and blinded patch application of capsaicin 8 or 004
Visit 2 Follow-up visit 1 D60 7 days Assessment - Patch renewal Patients with finger pain still greater than 410 may receive an open application of a capsaicin 8
Visit 3Follow-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-511159-16-00 | CTIS | None | None |