JPRN-jRCT2080223112已完成3 期
Efficacy and safety trial of AJG555 in patients with chronic constipation (Phase 3 study)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 156
研究概览
简要总结
Treatment with AJG555 was initiated at 2 sachets once a day in patients with chronic constipation for both the 2-wk Confirmatory phase and 52-wk Extension phase. Based on their bowel condition, the dose was adjusted in accordance with the Dose Adjustment Criteria. As a result, the superiority of AJG555 versus the placebo was demonstrated. Moreover, the efficacy of AJG555 lasted for the entire 52-wk Extension phase. the tolerability of AJG555 in patients with chronic constipation was considered acceptable.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 15age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patients with chronic constipation
排除标准
- •Patients with known or suspected organic constipation
- •Patients with known or suspected symptomatic constipation or drug-induced constipation
研究者
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