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Clinical Trials/NL-OMON39603
NL-OMON39603
Completed
Phase 3

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

Academisch Medisch Centrum0 sites65 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

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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