Acetylcysteine in patients with Sickle Cell Disease. Reducing the incidence of daily life pain in patients with sickle cell disease - N-Acetylcysteine in patients with Sickle Cell Disease

Academic Medical Center, Department of Haematology, University of Amsterdam0 个研究点目标入组 140 人开始时间: 2014年12月3日最近更新: 2015年2月16日

适应症

试验速览

暂无简介。

•- Age 12 years or older
•- Sickle cell disease, either homozygous sickle cell disease (HbSS), HbSC sickle cell
•disease, HbS0 or HbS+ thalassemia: Genotype needs to be confirmed by laboratory tests (high performance liquid chromatography).
•- History of at least 1.0 painful crisis per year in the past 3 years: A crisis will be defined here as a patient defined, painful, sickle cell related episode of at
•least 24 hours where a subject experienced significant impediments in his/her daily
•activities, and pain medication had to be taken. A visit to a medical facility is not obligatory in this definition.
•- Written informed consent from patient/parent/guardian is given.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 40
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•- Chronic blood transfusion or simple transfusion in the preceding 3 months
•- Painful crises in the past 4 weeks
•- Pregnancy, breast feeding or desire to get pregnant in the following 7 months
•- Known active gastric ulcers
•- Hydroxycarbamide treatment with unstable dose in the past 3 months or Hydroxycarbamide commenced less than 6 months prior to study
•- Insufficient compliance in the run in period (Participants that do not show up for their follow-up visit without prior notice, that not bring
•their diary or with less than 80% of the days in the pain diary filled in, will be excluded from participation in this trial and will not be randomized.)
•- Known poor compliance in earlier trials regarding the completion of pain diaries.
•- Known hypersensitivity to N-acetylcysteine or one of its components.
•- Use of pain medication for sickle-cell related pains on more than 15 days per month
•in the past 6 months (‘chronic pain’).

发起方

Academic Medical Center, Department of Haematology, University of Amsterdam