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Study of Clotrimazole and Hydroxyurea in Patients With Sickle Cell Syndromes
This study is currently recruiting participants.
Verified by FDA Office of Orphan Products Development, May 1998
First Received: October 18, 1999   Last Updated: June 23, 2005   History of Changes
Sponsors and Collaborators: FDA Office of Orphan Products Development
Children's Hospital Boston
Information provided by: FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier: NCT00004404
  Purpose

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.


Condition Intervention
Sickle Cell Anemia
Drug: clotrimazole
Drug: hydroxyurea

Genetics Home Reference related topics: sickle cell disease
MedlinePlus related topics: Anemia Sickle Cell Anemia
Drug Information available for: Miconazole nitrate Miconazole Clotrimazole Tioconazole Hydroxyurea
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment

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

Estimated Enrollment: 20
Study Start Date: April 1997
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004404

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kenneth R Bridges     617-432-1000        
Children's Hospital - Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Carlo Brugnara     617-355-6347        
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Study Chair: Carlo Brugnara Children's Hospital Boston
  More Information

No publications provided

Study ID Numbers: 199/13288, CH-B-97-052, CH-B-FDR001022
Study First Received: October 18, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00004404     History of Changes
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

Study placed in the following topic categories:
Hydroxyurea
Hematologic Diseases
Clotrimazole
Miconazole
Tioconazole
Anemia
Rare Diseases
Anemia, Hemolytic
Anti-Infective Agents, Local
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hemoglobinopathies
Antifungal Agents
Sickle Cell Anemia
Hemoglobinopathy
Anemia, Sickle Cell

Additional relevant MeSH terms:
Anti-Infective Agents
Antisickling Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hematologic Diseases
Clotrimazole
Hydroxyurea
Miconazole
Hematologic Agents
Anemia
Tioconazole
Anemia, Hemolytic
Enzyme Inhibitors
Pharmacologic Actions
Anemia, Hemolytic, Congenital
Anti-Infective Agents, Local
Genetic Diseases, Inborn
Therapeutic Uses
Hemoglobinopathies
Antifungal Agents
Anemia, Sickle Cell
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 07, 2009