EUCTR2004-002912-27-ES进行中（未招募）1 期
Open-Label Extension Study to Investigate the Continued Safety and Effect of ONO 2506PO (1200 mg OD).
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
- •Adult males and females aged over 18years.
- •Previous randomisation in clinical study ONO-2506PO/EU0106.
- •Completion of all visits in clinical study ONO-2506PO/EU0106.
- •Ability to swallow ONO-2506PO capsules.
- •Ability to comply with the dosing regimen and visit schedule.
- •Agreement for themselves or their partner to use an adequate method of contraception throughout the study and for 2 weeks post-study. Adequate methods of contraception for themselves or their partner include condoms, diaphragm with spermicidal gel, coil (intra-uterine device), surgical sterilisation, vasectomy and abstinence.
- •Able and willing to give written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Requirement for any medications metabolised via the cytochrome P450 2C9 pathway and may compromise subject safety due to elevated plasma levels, or those listed in section 7.6.2.
- •A clinically relevant medical history or presence of cardiovascular, gastrointestinal, renal, hepatic, endocrine/metabolic, neurologic, lymphatic, haematologic, immunologic, musculoskeletal, connective tissue, dermatologic, genito/urinary, psychiatric diseases or disorders that, in the opinion of the Investigator, may pose an unwarranted risk to the subject.
- •Previous participation in any ONO-2506 study, with the exception of ONO-2506PO/EU0106.
- •Previous participation in any other study since their participation in study ONO-2506PO/EU0106.
- •Presence or intention of pregnancy and breast-feeding (female subjects only).
- •Males with the intention of fathering a child during the study period.
研究者
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