NCT01844180已完成2 期
A Phase 2, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ONO-2952 in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 48
- 主要终点
- Abdominal pain or stool symptoms in female subjects with IBS-D by using a numeric pain rating scale and the Bristol Stool Scale (BSS)
研究概览
简要总结
The objective of this study is to explore efficacy, safety and tolerability of ONO-2952 in female subjects with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D).
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female 18-65 years of age (inclusive)
- •Diagnosed with IBS based on the following criteria (Rome III criteria):
- •Symptom onset at least 6 months prior to diagnosis, and
- •Recurrent abdominal pain or discomfort at least 3 days per month for the past 3 months, and
- •Abdominal discomfort or pain associated with two or more of the following at least 25% of the time:
- •Improvement with defecation
- •Onset associated with a change in frequency of stool/defecation
- •Onset associated with a change in form (appearance) of stool
- •Diagnosed with IBS-D, defined as loose/watery stools ≥ 25% and hard/lumpy stools ≤ 25% of defecations
排除标准
- •Any structural abnormality of the gastrointestinal (GI) tract (other than esophagitis or gastritis)
- •History of Crohn's disease, ulcerative colitis, diabetes mellitus, lactose malabsorption, malabsorption syndromes, celiac sprue, or any upper GI symptoms that may impact the assessment of IBS symptoms
研究组 & 干预措施
Experimental Arm 1
Experimental
ONO-2952 low dose every day for 4 weeks
干预措施: ONO-2952 (Drug)
Experimental Arm 2
Experimental
ONO-2952 high dose every day for 4 weeks
干预措施: ONO-2952 (Drug)
Placebo Arm
Placebo Comparator
ONO-2952 Matching Placebo every day for 4 weeks
干预措施: ONO-2952 Matching Placebo (Drug)
结局指标
主要结局
Abdominal pain or stool symptoms in female subjects with IBS-D by using a numeric pain rating scale and the Bristol Stool Scale (BSS)
时间窗: 4 weeks
次要结局
- Safety assessed through adverse events and clinical laboratory values(4 weeks)
- Change in IBS related symptoms and quality of life (QoL) by questionaire assessments(4 weeks)
研究者
研究点 (48)
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