AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 3Ages 18 Years - anyAllNantes University Hospital
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
๐Ÿ’Š

What it tests

  • Capsaicin 179 Mg Cutaneous Patch
  • Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2)
๐Ÿ“

Where

6 sites
Brest University Hospital
Brest, France
Vendรฉe Departmental Hospital
La Roche-sur-Yon, France
Confluent Private Hospital Centre
Nantes, France
Nantes University Hospital
Nantes, France
GH Paris saint Joseph
Paris, France
Rouen University Hospital
Rouen, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy