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Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.

Study acronym: CAPSACOX
StatusRecruiting
PhasePhase 3
Started2023-11-08
View on ClinicalTrials.gov ↗

Amendment history

2026-02-20
Study Status v6
Re-verified, no change to tracked fields
2024-07-25
Study Status, Eligibility v5
Eligibility criteria+115 characters
[...] of previous treatments: NSAIDs, pressure-relieving cushions, and/or infiltration (foror hypermobilehaving coccygodynia)a contraindication to these treatments, or not wishing to receive these treatments Have never been treated with an 8% capsaicin patch for this [...] atorship, legal protection) Pregnant or breast-feeding women Patients who have undergone total coccygectomy
2024-04-25
Study Status, Contacts/Locations v4
Study sitesdetails revised at 4 of 6 sites
2024-01-19
Study Status, Contacts/Locations v3
Primary completion date2027-01-01→2027-01-08
Completion date2027-06-01→2027-06-08
Start dateestimated 2023-11-15→confirmed 2023-11-08
Study sitesdetails revised at 2 of 6 sites
2023-11-10
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-02-01→2027-01-01
Completion date2027-05-01→2027-06-01
Start date2023-10-01→2023-11-15
Study sitesdetails revised at 6 of 6 sites
2023-09-07
Study Status, Outcome Measures v1
Secondary endpoints9 entries, revised
Analysis of primary and secondary endpoints according to the presence or absence of sacrococcygeal sacrococcygeal hypermobility.
2023-09-04
Original filing
The primary objective is to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia.
Trial Details
NCT Number NCT06023706
Lead Sponsor Nantes University Hospital
Conditions Coccyx Disorder, Neuropathic Pain, Coccygodynia
Enrollment 188 participants
Start Date 2023-11-08
Primary Completion 2027-01-08 (estimated)
Study Completion 2027-06-08 (estimated)
Updated on ClinicalTrials.gov 2026-02-24