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

Официальное название

Phase 3 Confirmatory, Randomised 1:1 Double-blind, Placebo-controlled Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.

Обзор

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

Подробное описание

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).

Вмешательства

• Препарат Capsaicin 179 Mg Cutaneous Patch
  1 patch applied once for 1 hour
• Препарат Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2)
  1 patch applied once for 1 hour

Первичные конечные точки

• to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia. [Срок оценки: Day 60]

Вторичные конечные точки (9)

• Evaluation of the tolerability of the 8% capsaicin patch compared to low concentration capsaicin patch (control) within the first 7 days [Срок оценки: 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)]
• Evaluate the safety of the capsaicin 8% patch compared with the control patch throughout the study. [Срок оценки: Throughout the study (an average of 5 months)]
• Evaluation of the analgesic effect over time and maintenance of effect in the two treatment groups over the entire study. [Срок оценки: Day 2, Day 7, Day 15, Day 21, Day 30, Day 45, Day 60, Day 90, Day 120 and Day 150.]
• Evaluation of health care consumption in the two treatment groups over the entire study period (5 months). [Срок оценки: Over 5 months]
• Evaluation of health care consumption in the two treatment groups over the entire study period (5 months). [Срок оценки: Over 5 months]
• Evaluation of the cost-utility of 8% capasaicin patch with common clinical practice over a time horizon of 5 months [Срок оценки: Over a time horizon of 5 months]
• Analysis of primary and secondary endpoints according to the presence or absence of sacrococcygeal hypermobility. [Срок оценки: At inclusion]
• Determination of the therapeutic response to 8% capsaicin patch [Срок оценки: Day 60]
• 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. [Срок оценки: Between Day 0 and Day 60]

Критерии участия

Критерии включения

• >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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Франция · 6 центров

• Brest University Hospital — Brest
• Vendée Departmental Hospital — La Roche-sur-Yon
• Confluent Private Hospital Centre — Nantes
• Nantes University Hospital — Nantes
• GH Paris saint Joseph — Paris
• Rouen University Hospital — Rouen

Идентификаторы

NCT: NCT06023706 · RC22_0415

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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