NCT00584298已完成1 期
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Women With Irritable Bowel Syndrome to Evaluate Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using Octreotide.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- - 5 sensory pressure thresholds [mmHg] from ascending method of limits (AML) barostat protocol. - 16 sensory intensity ratings from the random phasic distention (RPD) barostat protocol.
研究概览
简要总结
This study is designed to provide information on feasibility and reproducibility of barostat assessments of colorectal sensory functions and compliance and their pharmacological modulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •A positive diagnosis of IBS.
- •Subjects must either have been surgically sterilized, hysterectomized at least 6 months prior to screening, be postmenopausal or be using a double-barrier local
- •contraception.
- •Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent
排除标准
- •History of or evidence for structural diseases/conditions that affect the gastrointestinal system.
- •Other diseases or conditions that in the opinion of the Investigator significantly affect colorectal sensitivity.
- •Evidence of occult blood at stool analysis, or history of rectal bleeding.
- •Using or planning to use drugs or agents during the study period that alter GI physiology and visceral perception.
研究组 & 干预措施
1
Experimental
干预措施: SMS995 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
- 5 sensory pressure thresholds [mmHg] from ascending method of limits (AML) barostat protocol. - 16 sensory intensity ratings from the random phasic distention (RPD) barostat protocol.
时间窗: throughout the study
次要结局
- - colorectal compliance(throughout the study)
研究者
研究点 (1)
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