NCT00004492

Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of North Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: 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.

Detailed description

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

Conditions

• Sickle Cell Anemia

Interventions

Type	Name	Description
DRUG	clotrimazole
DRUG	hydroxyurea

Timeline

• Start date: 1999-10-01
• Completion: 2001-09-01
• First posted: 1999-10-19
• Last updated: 2015-03-25

Locations

1 site across 1 country: United States