jRCT2031260148尚未招募不适用
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants With IBS-D (J2S-MC-GZMS)
未提供0 个研究点目标入组 531 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 531
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18age old over 至 75age old under（—）
- 性别
- All
入选标准
- •Meet Rome IV criteria for IBS-D, which includes having greater than 25% of bowel movements with Bristol Stool Form Scale (BSFS) Types 6 or 7 and <25% of bowel movements with BSFS Types 1 or 2
- •Based on the daily eDiary collection during the screening period:
- •Have average of worst abdominal pain score of >=3.0 on a 0-to-10-point scale during the 14 consecutive days prior to randomization
- •Have at least 4 days per week with a maximum BSFS >=5 AND with at least 2 days of the 4 days per week with a maximum BSFS >=6 during the 14 consecutive days prior to randomization
- •Have had no major changes in diet in the 4 weeks prior to screening
排除标准
- •Have a diagnosis of IBS with a subtype of constipation, mixed IBS, or unclassified IBS by the Rome IV criteria
- •Have a history of inflammatory or immune-mediated gastrointestinal disorders
- •Have a known clinically significant gastric emptying abnormality
研究者
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