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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28196

Enrollment

140

Registered

2013-01-22

Start date

2013-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease Sickle Cell Anemia Painful Crisis Pain Sikkelcel ziekte Sikkelcel anemie Pijnlijke crise Pijn

Interventions

Experimental: N-Acetylcysteine (N-Acetylcysteine 600mg 1 oral tablet twice daily during 6 months). Placebo Comparator: (Placebo 1 oral tablet twice daily during 6 months).

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

Measure	Time frame
The frequency of SCD related pain in daily life in patients with Sickle Cell Disease evaluated over a period of 6 months.	—

Secondary

Measure	Time frame
1. 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.	—

Measure

Time frame

1. 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.

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Contacts

Public ContactJ. Sins

Dept. of Hematology & Pediatric Hematology Academic Medical Center, Amsterdam

j.w.sins@amc.nl+31 (0)20 5661693

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)