NCT02961556已完成3 期
General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change from the second week of the screening period in the number of spontaneous bowel movements (SBMs) at the second week of the administration period
研究概览
简要总结
This baseline-controlled, open-label, multicenter study evaluates the efficacy and safety of AJG555 orally administered for 2 weeks in pediatric participants with chronic constipation. The safety and efficacy of 12 weeks of administration will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Participants with chronic constipation
- •Age: 2 years old or older and 14 years old or younger (at the time of the informed consent)
- •Gender: N/A
排除标准
- •Main Exclusion Criteria:
- •Participants with organic constipation or participants suspected of having organic constipation
- •Participants with symptomatic constipation or participants suspected of having symptomatic constipation
- •Participants with drug-induced constipation or participants suspected of having drug-induced constipation
研究组 & 干预措施
AJG555
Experimental
After 2 weeks of the screening period, participants will be administered AJG555 starting on the day of the formal enrollment and continuing for 12 weeks.
干预措施: AJG555 (Drug)
结局指标
主要结局
Change from the second week of the screening period in the number of spontaneous bowel movements (SBMs) at the second week of the administration period
时间窗: Screening; Week 2 of administration period
次要结局
- Change from the second week of the screening period in the number of complete SBMs (CSBMs) at each week of the administration period(Screening; up to Week 12 of administration period)
- Usage of rescue medication(up to Week 12 of administration period)
- Change from the screening period in the number of CSBMs at two weeks after the initiation of the administration(Screening; Week 2 of administration period)
- Percentage of responders for SBM and CSBM at each week of the administration period(up to Week 12 of administration period)
- Number of pouches of AJG555 administered(up to Week 12 of administration period)
- Change from the second week of the screening period in the number of SBMs at each week of the administration period(Screening; up to Week 12 of administration period)
- Change from the screening period in the number of SBMs at two weeks after the initiation of the administration(Screening; Week 2)
- Number of days until SBM and CSBM(up to Week 12 of administration period)
- Change from the second week of the screening period in the total number of SBMs at each week of the administration period(Screening; up to Week 12 of administration period)
- Stool consistency measured by the Bristol stool form scale(up to Week 12 of administration period)
- Duration of administration of AJG555(up to Week 12 of administration period)
研究者
研究点 (2)
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