Study of Clotrimazole and Hydroxyurea in Patients With Sickle Cell Syndromes

This study has been completed.
Children's Hospital Boston
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: October 18, 1999
Last updated: March 24, 2015
Last verified: May 1998


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.

Condition Intervention
Sickle Cell Anemia
Drug: clotrimazole
Drug: hydroxyurea

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 20
Study Start Date: April 1997
Estimated Study Completion Date: September 2002
Detailed Description:


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.

Completion date provided represents the completion date of the grant per OOPD records


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


--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
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Please refer to this study by its identifier: NCT00004404

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Children's Hospital - Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hosptial of Boston
Children's Hospital Boston
Study Chair: Carlo Brugnara Children's Hospital Boston
  More Information

No publications provided Identifier: NCT00004404     History of Changes
Other Study ID Numbers: 199/13288, CH-B-97-052, CH-B-FDR001022
Study First Received: October 18, 1999
Last Updated: March 24, 2015
Health Authority: United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
genetic diseases and dysmorphic syndromes
hematologic disorders
rare disease
sickle cell anemia

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses processed this record on October 02, 2015