Standard Treatment Or topical doxepin against Pruritusin burn patients - STOP trial

Association of Dutch Burn Centres0 个研究点开始时间: 2013年7月23日最近更新: 2013年7月29日

试验速览

暂无简介。

•Patients with healed burns and itch. Patients are divided into four groups i.e.
•1) patients with partial thickness wounds, not exceeding 4 months postburn
•2) patients with full thickness wounds, not exceeding 4 months postburn
•3) patients with partial thickness wounds between 4 months postburn and 3 years postburn
•4) patients with full thickness wounds between 4 months postburn and 3 years postburn
•Itch intensity as assessed by VAS score greater than or equal to 3
•Patients treated in one of the three Dutch burn centres
•Patients aged 18 years or older
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 103
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•- Inability to give informed consent by patient or legal representatives
•- Inability to understand and fill in VAS scores and quality of life/pruritus assessment questionnaires, as judged by the treating physician
•- (Active) cutaneous or systemic disease causing itch
•- Any disease or condition which, according to the physician's judgement, is associated with adverse effects using doxepin, that is:
•Contra-indications Tavegil
•- hypersensitivity to clemastine or other arylalkylamine antihistamines, or any of the excipients
•- porphyria
•Precautions Tavegil:
•- fructose intolerance
•- narrow-angle glaucoma
•- stenosing peptic ulcer
•- pyloroduodenal obstruction
•- prostatic hypertrophy with urinary retention and bladder neck obstruction
•- galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
•- pregnancy and lactation
•Contra-indications Xepin:
•- hypersensitivity to any of its components.
•Precautions Xepin
•- glaucoma
•- a tendency to urinary retention
•- severe liver disease
•- severe heart disease (including cardiac arrythmias)
•- pregnancy and lactation

发起方

Association of Dutch Burn Centres