NL-OMON39603
Completed
Phase 3
Reducing the incidence of daily life pain in patients with sickle cell disease - NAC Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 65
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •\-Use of pain medication for sickle\-cell related pains on more than 15 days per month in the past 6 months (\*chronic pain\*).
Outcomes
Primary Outcomes
Not specified
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