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Sponsors and Collaborators: |
FDA Office of Orphan Products Development University of North Carolina |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004492 |
OBJECTIVES:
I. Compare the efficacy of hydroxyurea with or without clotrimazole in terms of limiting the severity of anemia and the rate of hemolysis in patients with sickle cell anemia.
Condition | Intervention | Phase |
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Sickle Cell Anemia |
Drug: clotrimazole Drug: hydroxyurea |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Estimated Enrollment: | 20 |
Study Start Date: | October 1999 |
PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
Arm I: Patients receive oral hydroxyurea and oral clotrimazole daily for 12 months.
Arm II: Patients receive oral hydroxyurea daily for 12 months. Patients are followed at 6 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Diagnosis of sickle cell anemia confirmed by hemoglobin electrophoresis
Received hydroxyurea for at least 6 months On a stable dose for at least 3 months Tolerating dose of at least 5 mg/kg/day
--Prior/Concurrent Therapy--
Chemotherapy:
Other: No concurrent drug that may interact with or influence the metabolism of hydroxyurea or clotrimazole
--Patient Characteristics--
Hematopoietic: WBC at least 4000/mm3 Platelet count at least 150,000/mm3 Hemoglobin less than 11 g/dL
Hepatic: AST/ALT no greater than 100 units/L
Renal: Creatinine no greater than 1.5 mg/dL
Other:
United States, North Carolina | |
University of North Carolina School of Medicine | Recruiting |
Chapel Hill, North Carolina, United States, 27599-7070 | |
Contact: Eugene Paul Orringer 919-843-9486 |
Study Chair: | Eugene Paul Orringer | University of North Carolina |
Study ID Numbers: | 199/14273, UNCCH-FDR001531 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004492 |
Health Authority: | United States: Federal Government |
genetic diseases and dysmorphic syndromes hematologic disorders rare disease sickle cell anemia |
Hydroxyurea Hematologic Diseases Clotrimazole Miconazole Anemia Rare Diseases Tioconazole |
Anemia, Hemolytic Sickle cell anemia Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Hemoglobinopathies Hemoglobinopathy Anemia, Sickle Cell |
Anti-Infective Agents Anti-Infective Agents, Local Antisickling Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antifungal Agents |
Therapeutic Uses Hematologic Agents Enzyme Inhibitors Nucleic Acid Synthesis Inhibitors Pharmacologic Actions |