NCT03875261Unknown2 期
Effect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis
David Garcia Cinca1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pressure threshold in hypogastrium that induces pain
研究概览
简要总结
This study evaluates the treatment of the symptoms of deep endometriosis with a cannabinoid derivate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between the ages of 18 and
- •Diagnosis of deep endometriosis after clinical suspicion and confirmation by imaging test.
- •Pain with a score of 4 or more on a numerical visual scale of 11 levels (EVN 0-10) in the last 3 months (includes any type of pain associated with endometriosis: dysmenorrhea, dyspareunia, dyschezia, dysuria and / or pelvic pain).
- •Women of childbearing age * should have a negative pregnancy test before inclusion in the study and should commit to using highly effective contraceptive methods (hormonal contraceptives, intrauterine device, intrauterine hormonal release systems, bilateral tubal occlusion, vasectomy the couple, barrier methods and sexual abstinence) during the entire duration of the study and up to 3 months after the end of it.
- •Acceptance of participation in the study by signing the informed consent.
排除标准
- •Patients previously submitted to open abdominal surgery.
- •History of cancer.
- •Suspicion or diagnosis of endocrine, cardio-vascular or systemic pathology relevant.
- •Pregnancy or anticipation of pregnancy up to 3 months after the end of the study.
- •Current breastfeeding.
- •Use of hormonal treatment (combined oral contraception, progestin in the 3 months prior to the study, GNRH analogs in the 6 months prior to the start of the study).
- •Use of other analgesics different from those allowed in the study.
- •Recreational or pharmacological use of cannabinoids.
- •Hypersensitivity to cannabinoids or any of the exceptions.
- •Known or suspected personal history, or family history of schizophrenia or other psychotic illnesses, severe personality disorder or other major psychiatric disorders.
- •Patients with liver or kidney failure, severe cardiovascular disease and a history of epilepsy or recurrent seizures.
- •Patients who use concomitant potent enzyme inducers of CYP3A4, such as rifampicin, carbamazepine, phenytoin, phenobarbital, and St. John's wort.
研究组 & 干预措施
Study arm
Experimental
Participants are treated with the investigational medical product
干预措施: Cannabinoid treatment (Drug)
结局指标
主要结局
Pressure threshold in hypogastrium that induces pain
时间窗: day 30 after treatment initiation
Pain threshold versus mechanical stimulation in hypogastrium (anterior central L2 dermatoma) measured in kPa
次要结局
- Temperature threshold in dermatomes that induces pain(baseline, day 15, day 30 and day 45)
- Intensity of the general pain(baseline, day 15, day 30 and day 45)
- Anxiety and depression combined scale(baseline, day 15, day 30 and day 45)
- Pressure threshold in dermatomes that induces pain(baseline, day 15, day 30 and day 45)
- Cognitive disorder measured by a list of words(baseline, day 15, day 30 and day 45)
- about sleep quality(baseline, day 15, day 30 and day 45)
- Quality of Life(baseline, day 15, day 30 and day 45)
- Central sensitivity(baseline, day 15, day 30 and day 45)
研究者
David Garcia Cinca
Clinical Research Manager
Hospital Clinic of Barcelona
研究点 (1)
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