Status:
COMPLETED
Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial
Lead Sponsor:
UCSF Benioff Children's Hospital Oakland
Conditions:
Vaso-occlusive Pain Episodes
Eligibility:
All Genders
3-21 years
Phase:
PHASE2
Brief Summary
Vaso-occlusion contributes significantly to morbidity in sickle cell disease (SCD). Vaso-occlusive painful episodes (VOE) are common and debilitating, causing the majority of emergency department visi...
Eligibility Criteria
Inclusion
- Established Diagnosis of Sickle Cell Disease(SS,SC,S-beta thal)
- Admitted to Hospital for pain
- Pain requiring hospitalization for parenteral narcotics, not attributable to non-sickle cell causes
- \>3 year and older
Exclusion
- Hemoglobin less than 5gm/dL or immediate need for red cell transfusion
- Hepatic Dysfunction: increased in SGPT to \>2x normal value
- Renal Dysfunction: increased in creatinine to \>2x normal value or \>1.5
- Mental status or neurological changes
- Pregnancy
- \>10 Hospitalizations per year or history of dependance to narcotics
- Inability to take oral medications or allergy to arginine
- Inability to use a PCA device
- \< 3 years of age
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01796678
Start Date
September 1 2000
End Date
June 1 2007
Last Update
July 31 2013
Active Locations (1)
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1
Childrens Hospital Research Center Oakland
Oakland, California, United States, 94609