NCT00149877已完成4 期
Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Number of complete spontaneous bowel movement (csbm) during the first 4 weeks of treatment.
研究概览
简要总结
Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a new class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists. The aim of this study is to investigate the efficacy, safety and tolerability of tegaserod on bowel habits in patients with CC.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females of at least 18 years of age
- •A 12-month history of constipation (defined as < three spontaneous bowel movements per week and ≥1 of the following symptoms >25% of the time: hard stools, sensation of incomplete evacuation and straining)
排除标准
- •Patients with cancer, inflammatory bowel disease or other structural bowel disease
- •Patients who participated in a prior tegaserod study
- •Evidence of cathartic colon or laxative abuse, pelvic floor dysfunction or neurological disorders
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Number of complete spontaneous bowel movement (csbm) during the first 4 weeks of treatment.
次要结局
- Number of csbm during 8 weeks of treatment.
- Daily assessment of bowel habits:frequency, form, straining, feeling of complete evacuation.
- Daily patients' assessment: bowel habits, constipation, distention/bloating, abdominal discomfort pain.
- Laxative use.
- Safety and tolerability.
研究者
研究点 (2)
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