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

Phase 1

Completed

• Conditions: Sickle Cell Anemia

• Registration Number: NCT00004492
• Lead Sponsor: University of North Carolina

Brief 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

Study Timeline

• Study Start: 1999-10
• Study First Submitted: 1999-10-18
• Study First Submitted QC: 1999-10-18
• Study First Posted: 1999-10-19
• Status Verified: 2001-01
• Study Completion: 2001-09
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of North Carolina School of Medicine; 🇺🇸 Chapel Hill, North Carolina, United States