EUCTR2010-018705-11-GR进行中（未招募）不适用
A SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS
ONO Pharmaceutical Co., Ltd.0 个研究点目标入组 376 人开始时间: 2011年1月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 376
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients will be eligible to participate in this study if they meet all of the
- •following criteria:
- •1. Completed 26 weeks of double-blind phase of Study ONO-
- •2. For females:
- •a. Patients of childbearing potential who agree to use an acceptable form
- •of birth control (i.e. double barrier method; diaphragm plus condom,
- •intrauterine device plus condom, hormonal contraception plus condom,
- •spermicidal gel plus condom, or abstinence) throughout the study and
- •until 2 months after the last dose;
- •b. Negative serum and urine human chorionic gonadotropin (hCG) assay
- •at Visit 9;
- •3. For males:
- •a. Agree to use a condom with spermicide when engaging in sexual
- •intercourse during participation in the study and until 2 months after the
- •b. Agree to refrain from sperm donation during participation in the study
- •and until 2 months after the last dose;
- •4. Able and willing to provide signed, written, Informed Consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 376
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients will not be eligible to participate in this study if any of the
- •following criteria apply:
- •1. Presence of any dermatological abnormalities during Study ONO-
- •4641POU006 that in the opinion of the investigator or the Sponsor (Ono
- •Pharmaceutical Co., Ltd.) could increase the risk of the patient
- •developing a skin cancer;
- •2. In the opinion of the Investigator, a patient who may not be able to
- •cooperate fully with the study staff, may have difficulty in some study
- •requirements, or is otherwise not qualified for the study.
研究者
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