Study of Clotrimazole and Hydroxyurea in Patients With Sickle Cell Syndromes
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: N/A
Status: Recruiting
Sponsored by: FDA Office of Orphan Products Development Official(s) and/or principal investigator(s):
Carlo Brugnara, Study Chair, Affiliation: Children's Hospital Boston
Summary
OBJECTIVES:
Determine the effectiveness of the combined use of clotrimazole and hydroxyurea on a
specific panel of red cell characteristics in patients with sickle cell syndromes.
Clinical Details
Study design: Treatment
Detailed description:
PROTOCOL OUTLINE:
Patients receive oral hydroxyurea either once or twice daily plus oral clotrimazole twice
daily after meals for 6 months. Patients are assessed at 3 and 6 months during treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
PROTOCOL ENTRY CRITERIA:
- -Disease Characteristics-- Sickle cell syndromes characterized by vaso-occlusive crises
sufficiently severe to require prophylactic therapy Three or more crises per year
sufficiently severe to require hospitalization Stable dose of hydroxyurea for at least 4
months required - -Prior/Concurrent Therapy-- No treatment with any other antisickling
agents within the past 4 months Biologic therapy: No transfusion within 90 days No
concurrent chronic transfusions allowed (defined as more than one transfusion per month
for 2 or more months) Chemotherapy: See Disease Characteristics Endocrine therapy: Not
specified Radiotherapy: Not specified Surgery: Not specified Other: No chronic medications
that alter neurologic, renal, or hepatic functions
- Patient Characteristics-- Performance status: Karnofsky 70-100%
Hematopoietic: WBC within normal limits Platelet count within normal limits Hepatic:
No history of chronic liver disease Bilirubin less than 2 times normal SGOT and SGPT
less than 2. 5 times normal No severe hepatic damage Renal: Creatinine within normal
limits No severe renal damage Neurologic: No severe neurologic impairment No recent
or progressive neurologic impairment Other: Not pregnant Fertile patients must use
effective contraception No allergies to hydroxyurea or clotrimazole
Locations and Contacts
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Kenneth R Bridges, Phone: 617-432-1000
Children's Hospital - Boston, Boston, Massachusetts 02115, United States; Recruiting
Carlo Brugnara, Phone: 617-355-6347
Additional Information
Starting date: April 1997
Last updated: June 23, 2005
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