NCT06460038招募中2 期
Efficacy and Safety of Tenapanor in Synucleinopathy-Related Constipation
Cedar Valley Digestive Health Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Complete spontaneous bowel movements (CSBM)
研究概览
简要总结
Investigation of tenapanor as a potential treatment for synucleinopathy-associated constipation
详细描述
Randomized, double-blind, placebo controlled trial of tenapanor vs. placebo for treating synucleinopathy-associated constipation in Parkinson's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tenapanor
Experimental
Tenapanor 50 mg orally twice daily for 12 weeks
干预措施: Tenapanor (Drug)
Placebo
Placebo Comparator
Placebo orally twice daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Complete spontaneous bowel movements (CSBM)
时间窗: 6 of 12 weeks
Our primary endpoint will be CSBM response, defined as an increase of at least one CSBM per week compared to baseline for at least 6 of the 12 treatment weeks. A CSBM is defined as a bowel movement that occurs naturally and is accompanied by a feeling of complete evacuation
次要结局
- Abdominal pain and bloating response(6 of 12 weeks)
- Lipopolysaccharide binding protein(Week 12)
- Calprotectin(Week 12)
- Plasma zonulin(Week 12)
- Complete spontaneous bowel movements (CSBM) continuous(Week 12)
研究者
研究点 (1)
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