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

RecruitingPhase 3NCT06023706
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
Phase 3 Confirmatory, Randomised 1:1 Double-blind, Placebo-controlled Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.
Conditions
Interventions
  • Drug: Capsaicin 179 Mg Cutaneous Patch
  • Drug: Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2)
Sponsor
Nantes University Hospital
Start date
2023-11-08
Primary completion
2027-05-08
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
France
Total sites listed
6

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06023706