EUCTR2014-005594-36-GB进行中（未招募）1 期
A Phase IV, Randomised, Double-Blind, Controlled, Parallel Group Trial to Evaluate the Effectiveness and Safety of Balneum Plus vs Emollient in the Treatment of Uraemic Pruritus in Haemodialysis Patients. - The DON'T ITCH Trial.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 58
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •The participants must meet ALL of the following criteria to be considered eligible for the study:
- •Male or Female, aged 18 years or above.
- •Receiving haemodialysis for the treatment of ESRD for at least 3 months.
- •Participant is willing and able to give informed consent for participation in the study.
- •Self reported symptoms of uraemic pruritus. Itch will be defined as at least 3 episodes of itch during the last 2 weeks, several times a day for more than 5 minutes and being bothersome20.
- •VAS score of at least 2cm
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 29
排除标准
- •The participant may not enter the study if ANY of the following apply:
- •Any other skin condition e.g. psoriasis, atopic dermatitis
- •Taking any oral medication for UP other than antihistamines e.g. opiates, gabapentin
- •Acute erythroderma, acute inflammatory, oozing or infected skin lesions
- •Use of topical skin medication containing any active ingredients (anything other than simple emollient)
- ••Any chronic liver disease in the participant’s past medical history that may cause itch, as deemed by the assessing clinician.
- •Solid organ malignancy
- •Cognitive impairment that may impact on their ability to fill in the quality of life questionnaire e.g. a previous diagnosis of dementia.
- •Lack of a good understanding of English.
- •Unwilling to apply the topical treatment as prescribed, including a previous history of poor-compliance with any treatment.
- •Significant ongoing illness requiring inpatient treatment.
- •Allergy to Balneum Plus or any of its ingredients.
- •Breastfeeding
研究者
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