NCT00004404已完成不适用
Study of Clotrimazole and Hydroxyurea in Patients With Sickle Cell Syndromes
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
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.
Completion date provided represents the completion date of the grant per OOPD records
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell AnemiaSickle Cell AnemiaNCT00004492University of North Carolina20
已完成
2 期
Hydroxy Urea, Omega 3, Nigella Sativa,Honey on Oxidative Stress and Iron Chelation in Pediatric Major ThalassemiaIron OverloadOxidative StressThalassemia MajorNCT04292314Beni-Suef University350
已完成
2 期
Combination Therapy of Hydroxyurea With L-Carnitine and Magnesium Chloride in Thalassemia Intermediaβ-Thalassemia IntermediaNCT00809042Shiraz University of Medical Sciences120
已完成
2 期
Clinical Experience of Thalidomide in Thalassemic PatientsThalassemia, BetaNCT05132270Children's Hospital Karachi135
已完成
3 期
Multicenter Study of Hydroxyurea in Patients With Sickle Cell Anemia (MSH)Anemia, Sickle CellHematologic DiseasesHemoglobinopathiesNCT00000586National Heart, Lung, and Blood Institute (NHLBI)