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Recruiting Phase 3

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

NCT06023706 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2023-11-08
Last updated
2026-10-09

Condition(s) studied

Coccyx DisorderNeuropathic PainCoccygodynia

Investigational drug(s) / intervention(s)

Capsaicin 179 Mg Cutaneous Patch →Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2)

Capsaicin 179 Mg Cutaneous Patch: 1 patch applied once for 1 hour

Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2): 1 patch applied once for 1 hour

Study summary

The primary objective is to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * \>18 years old at the pre-inclusion visit * Presenting with chronic coccygodynia: pain in the coccygeal region, increased by sitting and or when rising from a sitting position and pain over the last ten days of intensity greater than or equal to four on the eleven-point numerical scale (from zero to ten) and having been present for more than 3 months. * Failure of previous treatments: NSAIDs, pressure-relieving cushions and/or infiltration or having a contraindication to these treatments, or not wishing to receive these treatments * Have never been treated with an 8% capsaicin patch for this indication * With at least one clinical sign suggestive of neuropathic pain (burning, painful cold, numbness, tingling, electric discharge, allodynia of the gluteal groove, allodynia to pressure on the coccyx) * Proficiency in reading and writing the French language * Be affiliated to the social security system * Have signed an informed consent form * Women must meet one of the following criteria at the time of inclusion: * be using adequate contraceptive measures, and have a negative pregnancy test (specify if urine or blood test) prior to receiving the first dose of trial medication; * or be post-menopausal (aged over 50 with amenorrhoea for at least 12 months after stopping all exogenous hormonal treatments) * or (if under 50) have been in amenorrhoea for at least 12 months after stopping all exogenous hormone treatments and with luteinising hormone (LH) and follicle stimulating hormone (FSH) levels corresponding to post-menopausal levels. * or have undergone irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (this operation must be documented). Exclusion Criteria: * Coccygodynia accompanied by a dermatological lesion in the intergluteal cleft (psoriasis, pilodinial cyste, wound) * Patients with other major pain disorders likely to interfere with pain assessment * Hypersensitivity to capsaicin or to one of the excipients * Adults under legal protection (guardianship, curatorship, legal protection) * Pregnant or breast-feeding women * Patients who have undergone total coccygectomy

Primary outcome measure(s)

  • to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia. — Day 60
    The difference in the proportion of subjects improved (PGIC≤2) in either treatment group at day 60. It is expected that there will be a difference of at least 20% between treatment arms.

Trial sites (6)

FacilityCityRegionStatus
Brest University Hospital Brest France Recruiting
Vendée Departmental Hospital La Roche-sur-Yon France Recruiting
Confluent Private Hospital Centre Nantes France Recruiting
Nantes University Hospital Nantes France Recruiting
GH Paris saint Joseph Paris France Recruiting
Rouen University Hospital Rouen France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06023706 on ClinicalTrials.gov ↗ ← All trials in France