Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-06-08 @ 3:29 AM
Study NCT ID:
NCT00004492
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia
Sponsor:
University of North Carolina
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UNCCH-FDR001531 | None | None | View |