NCT06023706招募中3 期
Phase 3 Confirmatory, Randomised 1:1 Double-blind, Placebo-controlled Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 188
- 试验地点
- 6
- 主要终点
- to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia.
研究概览
简要总结
The primary objective is to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>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).
排除标准
- •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
研究组 & 干预措施
Capsaicin 179 mg cutaneous patch
Experimental
Capsaicin 179 mg cutaneous patch.
1 patch applied once for 1 hour at inclusion visit.
干预措施: Capsaicin 179 Mg Cutaneous Patch (Drug)
Capsaicin low concentration patch
Placebo Comparator
Capsaicin 0.04 cutaneous patch.
1 patch applied once for 1 hour at inclusion visit
干预措施: Capsaicin low concentration patch (capsaicin 0,04%, 3,2 mg/cm2) (Drug)
结局指标
主要结局
to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia.
时间窗: Day 60
The difference in the proportion of subjects improved (PGIC≤2) in either treatment group at day 60. It is expected that there will be a difference of at least 20% between treatment arms.
次要结局
- Analysis of primary and secondary endpoints according to the presence or absence of sacrococcygeal hypermobility.(At inclusion)
- Evaluation of the tolerability of the 8% capsaicin patch compared to low concentration capsaicin patch (control) within the first 7 days(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))
- 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.(Between Day 0 and Day 60)
- Determination of the therapeutic response to 8% capsaicin patch(Day 60)
- Evaluation of the analgesic effect over time and maintenance of effect in the two treatment groups over the entire study.(Day 2, Day 7, Day 15, Day 21, Day 30, Day 45, Day 60, Day 90, Day 120 and Day 150.)
- Evaluate the safety of the capsaicin 8% patch compared with the control patch throughout the study.(Throughout the study (an average of 5 months))
- Evaluation of the cost-utility of 8% capasaicin patch with common clinical practice over a time horizon of 5 months(Over a time horizon of 5 months)
- Evaluation of health care consumption in the two treatment groups over the entire study period (5 months).(Over 5 months)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
2 期
Study to Evaluate the Interest of Qutenza in Patients With Head and Neck Cancer in Remission and With Sequelae Neuropathic Pain.Head and Neck CancerNCT04704453Institut Claudius Regaud13
已完成
3 期
A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN)PainDiabetic Peripheral NeuropathyNCT01533428Astellas Pharma Inc369
已完成
不适用
A Study of Efficacy and Safety of Qutenza in Patients With Post-operative Peripheral Neuropathic PainPost-operative Peripheral Neuropathic PainNCT02171182Astellas Pharma s.r.o.319
终止
3 期
Capsaicin Patch 8 % for the Treatment of Persistent Pain After Inguinal HerniotomyPersistent Pain After Inguinal HerniotomyNCT01699854Rigshospitalet, Denmark50
已完成
4 期
Osteoarthritis Knee Pain Relief Study of 0.25% 920-CGS-200Osteoarthritis, KneeNCT03124407Propella Therapeutics120