NCT01849016

N-Acetylcysteine in Patients With Sickle Cell Disease

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	N-Acetylcysteine
DRUG	Placebo

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2013-05-08
• Last updated: 2016-07-04

Locations

11 sites across 3 countries: Belgium, Netherlands, United Kingdom