Status:
COMPLETED
N-Acetylcysteine in Patients With Sickle Cell Disease
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Erasmus Medical Center
Haga Hospital
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 hallmar...
Eligibility Criteria
Inclusion
- 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
- 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').
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01849016
Start Date
April 1 2013
End Date
June 1 2016
Last Update
July 4 2016
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Brugmann
Brussels, Belgium
2
CHU St. Pierre
Brussels, Belgium
3
Hôpital Erasme
Brussels, Belgium
4
Hôpital Universitaire Des Enfants Reine Fabiola (HUDERF)
Brussels, Belgium