Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004492
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Phase III Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia
Sponsor:
University of North Carolina
Organization:
FDA Office of Orphan Products Development
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 IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UNCCH-FDR001531 | None | None | None |