Clinical trial NCT06023706: Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.
Official title: Phase 3 Confirmatory, Randomised 1:1 Double-blind, Placebo-controlled Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Coccyx Disorder
Neuropathic Pain
Coccygodynia
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This trial is a French, multicenter, randomized, controlled, bouble-blind and prospective study. Patients enrolled will be clinically followed for 5 months. The treatment duration per subject is 1 hour (1time).

Eligibility criteria: 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 outcomes:
measure: to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia.
timeFrame: Day 60
Secondary outcomes:
measure: Evaluation of the tolerability of the 8% capsaicin patch compared to low concentration capsaicin patch (control) within the first 7 days
timeFrame: time 0 (prior to patch application), hour 1, 6, 12, 24, day 2 and day 7 and by collecting AEs during the study.time 0 (prior to patch application), hour 1, 6, 12, 24, day 2 and day 7 and through study completion (an average of 5 months)
measure: Evaluate the safety of the capsaicin 8% patch compared with the control patch throughout the study.
timeFrame: Throughout the study (an average of 5 months)
measure: Evaluation of the analgesic effect over time and maintenance of effect in the two treatment groups over the entire study.
timeFrame: Day 2, Day 7, Day 15, Day 21, Day 30, Day 45, Day 60, Day 90, Day 120 and Day 150.
measure: Evaluation of health care consumption in the two treatment groups over the entire study period (5 months).
timeFrame: Over 5 months
measure: Evaluation of health care consumption in the two treatment groups over the entire study period (5 months).
timeFrame: Over 5 months
measure: Evaluation of the cost-utility of 8% capasaicin patch with common clinical practice over a time horizon of 5 months
timeFrame: Over a time horizon of 5 months
measure: Analysis of primary and secondary endpoints according to the presence or absence of sacrococcygeal hypermobility.
timeFrame: At inclusion
measure: Determination of the therapeutic response to 8% capsaicin patch
timeFrame: Day 60
measure: Sensitivity study to compare results on the primary endpoint by comparing data from the PGI-C and a comparison of the two numerical pain assessments at Day 0 and Day 60.
timeFrame: Between Day 0 and Day 60
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest University Hospital
city: La Roche-sur-Yon
country: France
facility: Vendée Departmental Hospital
city: Nantes
country: France
facility: Confluent Private Hospital Centre
city: Nantes
country: France
facility: Nantes University Hospital
city: Paris
country: France
facility: GH Paris saint Joseph
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
References: