Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia
I. Compare the efficacy of hydroxyurea with or without clotrimazole in terms of limiting the severity of anemia and the rate of hemolysis in patients with sickle cell anemia.
|Sickle Cell Anemia||Drug: clotrimazole Drug: hydroxyurea||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||October 1999|
|Estimated Study Completion Date:||September 2001|
PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
Arm I: Patients receive oral hydroxyurea and oral clotrimazole daily for 12 months.
Arm II: Patients receive oral hydroxyurea daily for 12 months. Patients are followed at 6 weeks.
Completion date provided represents the completion date of the grant per OOPD records
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004492
|United States, North Carolina|
|University of North Carolina School of Medicine|
|Chapel Hill, North Carolina, United States, 27599-7070|
|Study Chair:||Eugene Paul Orringer||University of North Carolina|