Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia
Information source: FDA Office of Orphan Products Development
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sickle Cell Anemia
Intervention: clotrimazole (Drug); hydroxyurea (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: FDA Office of Orphan Products Development Official(s) and/or principal investigator(s):
Eugene Paul Orringer, Study Chair, Affiliation: University of North Carolina
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.
Clinical Details
Study design: Treatment, Randomized
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
PROTOCOL ENTRY CRITERIA:
- -Disease Characteristics--
Diagnosis of sickle cell anemia confirmed by hemoglobin electrophoresis
Received hydroxyurea for at least 6 months On a stable dose for at least 3 months
Tolerating dose of at least 5 mg/kg/day
- -Prior/Concurrent Therapy--
Chemotherapy:
- No other concurrent antisickling agent
Other: No concurrent drug that may interact with or influence the metabolism of
hydroxyurea or clotrimazole
- -Patient Characteristics--
Hematopoietic: WBC at least 4000/mm3 Platelet count at least 150,000/mm3 Hemoglobin less
than 11 g/dL
Hepatic: AST/ALT no greater than 100 units/L
Renal: Creatinine no greater than 1. 5 mg/dL
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior adverse reaction to hydroxyurea or clotrimazole
- No recent or progressive neurologic dysfunction
Locations and Contacts
University of North Carolina School of Medicine, Chapel Hill, North Carolina 27599-7070, United States; Recruiting
Eugene Paul Orringer, Phone: 919-843-9486
Additional Information
Starting date: October 1999
Last updated: June 23, 2005
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