NL-OMON27783尚未招募不适用
Treatment of itch with naltrexone in patients with burns: an explorative, randomised, double blind, placebo-controlled, cross-over clinical trial
G.I.J.M. Beerthuizen, M.D., Ph.D. Dept. of Surgery Martini HospitalP.O. box 300339700 RM GroningenThe NetherlandsT. Visser, Pharm.D.Dept. of PharmacyMartini HospitalP.O. box 300339700 RM GroningenThe Netherlands0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Eligible for inclusion are patients:
- •1. with (almost) healed burns who have been admitted to the burn centre;
- •2. are 18 years of age or older with itch 4-6 weeks postburn.
排除标准
- •Patients will be excluded when meeting one of the following exclusion criteria:
- •1. TBSA of more than 20%;
- •2. Liver insufficiency (in this study that means more than 2 times the normal range of the liverenzymes: ASAT> 80 U/L and/or ALAT >80 U/L and/or AF > 250U/L and/or gamma GT >100U/L);
- •3. Acute hepatitis;
- •4. History of drug/alcohol abuse;
- •5. Known sensitivity for any of the following substances: naltrexonehydrochloride, lactose monohydrate, crospovidone, powder cellulose, microcrystalline cellulose, colloid silicon dioxide, magnesium stearate, hypromellose, macrogole 4000, Titanium dioxide (E171), Black iron oxide (E172), Red iron oxide (E172), Yellow iron oxide (E172), carboxymethylamylum sodium type A, precirole.
- •6. Pregnant;
- •7. Breast feeding ;
- •8. Having used opioids 10 days prior to the start of treatment;
- •9. Using itch medication other than the study medication and unwilling to stop;
- •10. Psychiatric disorder;
- •11. Other disease associated with itch (eg excema, atopic dermatitis, cholestatic pruritus);
- •12. Insufficiently proficient in Dutch to give informed consent and/or fill out the questionnaires
研究者
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