NCT03833076已完成不适用
Evaluation of Performance and Safety of a New Medical Device Class IIb Not Yet CE Marked in Proctological Disorders: a Randomised, Double-blind, Parallel-groups, Multicentric, Placebo-controlled, Prospective Clinical Study.
Nathura S.p.A2 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2019年8月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Assessment of symptoms according to the Proctological Symptom Scale (PSS)
研究概览
简要总结
The aim of this study is primarily to investigate the performance of a new medical device not yet CE marked in comparison with placebo, in relieving proctological symptomatology in adult patients reporting symptoms of hemorrhoids (grade 1-3), anal fissures and proctitides.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes aged between 18 and 75 years.
- •Patients reporting symptoms of haemorrhoids (grade 1-3*), anal fissures and proctitides or already diagnosed with haemorrhoids (grade 1-3), anal fissures and proctitides; diagnosis confirmed by proctological examination at Screening Visit.
- •*Grade 1 - Haemorrhoid protrudes into the anal canal but does not prolapse outside the anus.
- •Grade 2 - Haemorrhoid protrudes through the anus during straining or evacuation but returns spontaneously.
- •Grade 3 - Haemorrhoid protrudes through the anus during straining or evacuation but needs to be manually returned to position.
- •Grade 4 - Haemorrhoid remains prolapsed outside of the anus.
- •Patients agreeing not to use any other systemic or topic medicinal / product to treat haemorrhoids, anal fissures and proctitides during the study and not to modify their personal hygiene products.
- •Female patients of childbearing potential following a reliable contraceptive method (according to Investigator's opinion).
- •Willingness to participate in the study and to sign an informed consent form.
排除标准
- •Patients presenting infective anal or rectal pathologies (in particular bacterial infections associated with proctitides or proctitides caused by viral infections).
- •Patients presenting complicated haemorrhoids.
- •Patients with Crohn's disease or malignancy.
- •Patients presenting undiagnosed abnormal rectal bleeding.
- •Patients with known or suspected rectal hypersensitivity.
- •Patients presenting coagulation disorders or on anticoagulant drug therapy (except clopidogrel or acetylsalicylic acid).
- •Patients in treatment with topic or systemic medications / products to treat haemorrhoids, fissures and proctitides, currently or in the 2 weeks prior to Screening Visit.
- •Patients using laxatives or stool softener currently or in the 2 weeks prior to Screening Visit.
- •Patients pregnant or breastfeeding.
- •Patients reporting past or present narcotic addiction or alcoholism.
- •Patients that participated in any other clinical trial during the last month or participating in any clinical trial while participating in this trial.
- •Patients reporting allergy or intolerance to any component of test product, placebo or rescue product.
- •Patients who in the opinion of the principal Investigator are at risk of non-compliance to the study procedures or who are otherwise not appropriate to include in this clinical trial.
- •Patients presenting contraindications to Proktis-M (rescue product), according to concerning leaflet.
结局指标
主要结局
Assessment of symptoms according to the Proctological Symptom Scale (PSS)
时间窗: from Day 0 to Day 14
Assessment of symptoms according to the Proctological Symptom Scale - PSS (according to 100 mm Visual Analogue Scales; from "no symptoms" to "overwhelming symptoms); comparison between groups, from Day 0 to Day 14
次要结局
- Self-assessment of overall treatment(from Day 0 to Day 14)
- Patient willingness(from Day 0 to Day 14)
- Investigator's assessment of signs(from Day 0 to Day 14)
- Self-assessment of subjective symptoms(from Day 0 to Day 14)
- Assessments done by Investigator of overall improvement(from Day 0 to Day 14)
- Assessment of rescue product(from Day 0 to Day 14)
研究者
研究点 (2)
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