ISRCTN68179235已完成不适用
Treatment of itch with naltrexone in patients with burns: an explorative, randomised, double blind, placebo-controlled, cross-over clinical trial
Martini Hospital (The Netherlands)0 个研究点目标入组 20 人开始时间: 2007年8月23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
- 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. Who are 18 years of age or older with itch 4 - 6 weeks post burn
排除标准
- •Patients will be excluded when meeting one of the following exclusion criteria:
- •1. Total Body Surface Area (TBSA) of more than 20%
- •2. Liver insufficiency (in this study that means more than two times the normal range of the liver enzymes: Aspartate Aminotransferase [ASAT] greater than 80 U/L and/or Alanine Aminotransferase [ALAT] greater than 80 U/L and/or Alkaline Phosphatase [AP] greater than 250U/L and/or Gamma Glutamyl Transpeptidase [GGT] greater than 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 (e.g. eczema, 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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