Reducing the incidence of daily life pain in patients with sickle cell disease

Phase 3

Completed

Conditions: Sickle cell pain
painful crisis
10018902

Registration Number: NL-OMON39603

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 65

Inclusion Criteria

- Age 12 years or older
- Either HbSS, HbSC, HbS*0- or HbS*+-thalassemia genotype
- History of at least 1.0 painful crisis per year in the past 3 years (hospital admission is not obligatory here).
- Written informed consent from patient/parent/guardian

Exclusion Criteria

- Chronic blood transfusion or transfusion in the preceding 3 months
- Painful crisis in the last 4 weeks (hospital admission is not obligatory here)
- Pregnancy, breastfeeding or the desire to get pregnant in the following 9 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 of 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*).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The frequency sickle cell-related pain in daily life </p><br>

Secondary Outcome Measures

Name	Time	Method
<p><br /><br>- The severity of sickle cell related pain in daily life.<br /><br>- The frequency and severity of painful crises in daily life.<br /><br>- The frequency and severity of hospital admission for painful crises<br /><br>- The health related quality of life,<br /><br>- Societal costs of SCD related care<br /><br>- Hematological markers of oxidative stress, hemolysis, hypercoagulability,<br /><br>inflammation and endothelial dysfunction.<br /><br>- The tolerability of NAC<br /><br>- The frequency of use of pain medication at home<br /><br>- The frequency of SCD complications (e.g. stroke)<br /><br>- Time in days to first painful crisis and first hospital admission</p><br>