NCT01362660已完成不适用
A Protocol to Monitor the Neurological Development of Infants With Exposure In-utero From Birth to Aged 15 Months in Tanezumab Clinical Studies at Investigational Sites Overseen by Schulman and Associates Institutional Review Board
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Bayley Infant Neurodevelopmental Screener
研究概览
简要总结
This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study).
详细描述
This study will enroll infants with potential tanezumab exposure in utero at sites overseen by Schulman and Associates IRB This study will attempt to enroll all infants who qualify.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is an infant born to a mother who was exposed to study drug on a tanezumab clinical study through direct maternal exposure; or is an infant born to a mother who is a partner of a male patient who was exposed to study drug in a tanezumab clinical study prior to or around the time of conception and/or is exposed during his partner's pregnancy.
排除标准
- •There are no exclusion criteria for this study
结局指标
主要结局
Bayley Infant Neurodevelopmental Screener
时间窗: 15 months
Receptive-Expressive Emergent Language Test
时间窗: 15 months
次要结局
未报告次要终点
研究者
研究点 (1)
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