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Study of Clotrimazole and Hydroxyurea in Patients With Sickle Cell Syndromes



Study of Clotrimazole and Hydroxyurea in Patients With Sickle Cell Syndromes

For Condition: Sickle Cell Anemia
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , Children's Hospital Boston
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 20

Location and Contact Information:

Overall Study Official:
CarloBrugnara,  Study Chair,  Children's Hospital Boston

Brigham and Women's Hospital *Recruiting*
Boston,  Massachusetts,  02115
United States
Recruiting Kenneth  Bridges 617-432-1000

Children's Hospital - Boston *Recruiting*
Boston,  Massachusetts,  02115
United States
Recruiting Carlo  Brugnara 617-355-6347


Additional Information:
Study ID Numbers:  199/13288;  CH-B-97-052,CH-B-FDR001022
Study Start Date: April 1997
Record last reviewed: May 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004404

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