Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital
About this trial
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 criteria
Qualifiers
>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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Capsaicin 179 Mg Cutaneous Patch
- Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2)
Treatment groups
188 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov