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van CCT (UK)

van CCT (UK)

N-Acetylcysteine in Patients With Sickle Cell Disease (NAC).

- candidate number14242
- NTR NumberNTR3806
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-jan-2013
- Secondary IDs2012-004892-37 / NL 41205.018.12; EudraCT / CCMO
- Public TitleN-Acetylcysteine in Patients With Sickle Cell Disease (NAC).
- Scientific TitleN-Acetylcysteine in Patients With Sickle Cell Disease: Reducing the Incidence of Daily Life Pain.
- hypothesisOur primary hypothesis is that the drug N-Acetylcysteine, a scavenger of free oxygen radicals and a precursor of glutathione, can reduce the frequency of daily life pain in patients with Sickle Cell Disease by reducing oxidative stress.
- Healt Condition(s) or Problem(s) studiedSickle cell disease, Pain, Painful crisis, Sickle Cell anemia
- Inclusion criteria1. Age 12 years or older;
2. Sickle cell disease, either homozygous sickle cell disease (HbSS), compound heterozygous sickle cell disease (HbSC), HbSβ0 or HbSβ+ thalassemia;
3. History of at least 1.0 painful crisis per year in the past 3 years (visit to medical facility is not required).
- Exclusion criteria1. Chronic blood transfusion or transfusion in the preceding 3 months;
2. Painful crisis in the last 4 weeks (with respect to the moment of inclusion);
3. Pregnancy, breast feeding or the desire to get pregnant in the following 7 months;
4. Known active gastric/duodenal ulcers;
5. Hydroxycarbamide (HC) treatment with change in dose in the last 3 months or started on HC shorter then 6 months prior to study;
6. Known poor compliance in earlier trials regarding the completion of pain diaries;
7. Insufficient compliance in run-in period;
8. Known hypersensitivity to acetylcysteine or one of the other components of the study medication.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2013
- planned closingdate1-okt-2014
- Target number of participants140
- InterventionsExperimental:
N-Acetylcysteine (N-Acetylcysteine 600mg 1 oral tablet twice daily during 6 months).

Placebo Comparator:
(Placebo 1 oral tablet twice daily during 6 months).
- Primary outcomeThe frequency of SCD related pain in daily life in patients with Sickle Cell Disease evaluated over a period of 6 months.
- Secondary outcome1. The severity of SCD related pain in daily life;
2. The incidence and severity of painful crises;
3. The frequency and length of hospital admissions;
4. The health-related Quality of Life;
5. The SCD-related societal costs;
6. The tolerability of NAC;
7. Frequency of use of pain medication at home;
8. Frequency of SCD complications (e.g. acute chest syndrome);
9. The changes in hematological markers of oxidative stress, hemolysis, hypercoagulability, inflammation, erythrocyte adhesion and endothelial dysfunction.
- TimepointsEvaluated over a 6 month intervention period with montly follow-up visits.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Amsterdam, ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryThe 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. We expect that NAC can reduce the frequency of pain in patients with SCD, thereby improving their quality of life and participation in society.
- Main changes (audit trail)
- RECORD22-jan-2013 - 26-apr-2013

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