Study of Clotrimazole and Hydroxyurea in Patients With Sickle Cell Syndromes
Recruitment status was Recruiting
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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 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 | |
| Study Chair: | Carlo Brugnara | Children's Hospital Boston |
More Information
No publications provided
| ClinicalTrials.gov 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: | June 23, 2005 |
| 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 Anemia, Sickle Cell Hematologic Diseases Anemia, Hemolytic, Congenital Anemia, Hemolytic Hemoglobinopathies Genetic Diseases, Inborn Clotrimazole Miconazole Hydroxyurea Anti-Infective Agents, Local |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antifungal Agents Antineoplastic Agents Antisickling Agents Hematologic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013