General Clinical Study of AJG555 in Pediatric Patients with Chronic Constipation

EA Pharma Co.,Ltd.0 个研究点目标入组 39 人开始时间: 2016年10月25日最近更新: 2023年10月17日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: EA Pharma Co.,Ltd.
入组人数: 39

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

To pediatric patients with chronic constipation, AJG555 was administered orally for 12 weeks starting with 1 or 2 sachets once daily according to age, then adjusting the dose based on the patient's status . The change in SBM frequency from Screening Period Week 2 to Treatment Period Week 2 was significantly increased. In addition, constipation-related improvements by AJG555 appeared torough 12 weeks. AJG555 administered for 12 weeks was considered tolerable.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 2age old 至 <= 14age old（—）
性别: All

入选标准

•-Patients with chronic constipation

排除标准

•- Patients with organic constipation or patients suspected of having organic constipation
•- Patients with symptomatic constipation or patients suspected of having symptomatic constipation
•- Patients with drug-induced constipation or patients suspected of having drug-induced constipation

研究者

发起方

EA Pharma Co.,Ltd.

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