NCT00004315Unknown2 期
Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease
National Center for Research Resources (NCRR)2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 1995年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
研究概览
简要总结
OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease.
II. Compare the differences in pruritus, weight gain, and liver function for both treatments.
详细描述
PROTOCOL OUTLINE:
Patients are sequentially treated with 2 formulations of ursodeoxycholic acid: unmodified ursodiol (Actigall) and buffered, enteric-coated ursodiol (Ursocarb). There is a 24-hour washout between each 4-week course of therapy.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 4 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Chronic cholestatic liver disease
- •Cystic fibrosis-associated liver disease
- •-Prior/Concurrent Therapy--
- •Usual and customary diet maintained throughout study, e.g., medium-chain triglyceride oil
- •-Patient Characteristics--
- •Pulmonary: No serious respiratory deficiency
- •No acute illness
- •No inability to swallow
- •No fertile women
排除标准
- 未提供
研究者
研究点 (2)
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