Trial | NCT01849016  Report issue

Title

N-Acetylcysteine in Patients With Sickle Cell Disease
N-Acetylcysteine in Patients With Sickle Cell Disease - Reducing the Incidence of Daily Life Pain

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    96
The primary aim of this study is to evaluate the effect of the drug N-Acetylcysteine on the frequency of pain in daily life in patients with Sickle Cell Disease (SCD).

Pain is an invalidating hallmark of this disease and has a considerable impact on the Quality of Life of patients and the medical health care system. Oxidative stress is hypothesized to play a central role in its pathophysiology. In pilot studies the administration of N-Acetylcysteine (NAC) resulted in a reduction of oxidative stress. Moreover, administration of NAC seemed to decrease hospitalization for painful crises in a small pilot study in patients with SCD.

This study will be performed as a multicenter, randomized, controlled trial where patients will be treated with either NAC or placebo for a period of 6 months. The investigators expect that NAC can reduce the frequency of pain in patients with SCD, thereby improving their quality of life and participation in society.
Study Started
Apr 30
2013
Primary Completion
Jun 30
2016
Study Completion
Jun 30
2016
Last Update
Jul 04
2016
Estimate

Drug N-Acetylcysteine

  • Other names: Acetylcysteine, Fluimicil, Acetadote

Drug Placebo

N-Acetylcysteine Experimental

N-Acetylcysteine 600mg 1 oral tablet twice daily during 6 months

Placebo Placebo Comparator

Placebo 1 oral tablet twice daily during 6 months

Criteria 

Inclusion Criteria:

Age 12 years or older
Sickle cell disease, either homozygous sickle cell disease (HbSS), compound heterozygous sickle cell disease (HbSC), HbSβ0 or HbSβ+ thalassemia
History of at least 1.0 painful crisis per year in the past 3 years (visit to medical facility is not required)

Exclusion Criteria:

Chronic blood transfusion or transfusion in the preceding 3 months
Painful crisis in the last 4 weeks (with respect to the moment of inclusion)
Pregnancy, breast feeding or the desire to get pregnant in the following 7 months
Known active gastric/duodenal ulcers
Hydroxycarbamide (HC) treatment with unstable dose in the last 3 months or started on HC shorter then 6 months prior to study
Known poor compliance in earlier trials regarding the completion of pain diaries
Insufficient compliance in run-in period
Known hypersensitivity to acetylcysteine or one of the other components of the study medication
Use of pain medication for sickle-cell related pains on more than 15 days per month in the past 6 months ('chronic pain').
No Results Posted