N-Acetylcysteine in patients with Sickle Cell Disease

• Research type

  Research Study

• Full title

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

• IRAS ID

  149035

• Contact name

  R.K. Kesse-Adu

• Contact email

  rachel.kesse-adu@gstt.nhs.uk

• Eudract number

  2012-004892-37

• ISRCTN Number

  ISRCTN28828586

• Clinicaltrials.gov Identifier

  NCT01849016

• Duration of Study in the UK

  1 years, 1 months, 1 days

• Research summary

  Pain is a hallmark of sickle cell disease (SCD) and it has considerable impact on quality of life of patients. Oxidative stress is hypothesised to play a central role in development of these painful episodes. Two pilot studies have showed administration of N-Acetylcysteine (NAC)tablets reduces markers of oxidative stress and is associated with reduced rates of hospitalisation for painful crises. This current study is hypothesising that NAC is able to reduce the frequency and severity of pain in the daily life of patients with SCD, hence it will assess the effect of administration of NAC on the frequency and severity of pain and painful crises daily, using patient kept pain diaries, additionally several blood markers will be monitored as will societal costs.
  Adult sickle cell patients who consent to go on the trial will be randomly assigned to one of two groups and receive either drug or placebo tablets twice daily for six months during which time they will keep a pain dairy, they will be reviewed monthly while on the trial at the end of which all the pain diaries from the two groups will be evaluated and compared. The study is hypothesising that the patients on NAC treatment will have less pain. It is an international and multi centre study which is presently being run in the Netherlands

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  14/LO/2220

• Date of REC Opinion

  30 Jan 2015

• REC opinion

  Further Information Favourable Opinion