NCT00171522已完成4 期
A Randomized, Open-label, Pilot Crossover Study to Assess the Patient Preference of Tegaserod Versus Polyethylene Glycol 3350 in Patients With 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
- 52
- 试验地点
- 28
- 主要终点
- To determine after 14 / 35 days of treatment if women with constipation have a preference for tegaserod compared to PEG 3350, based on the assessment of the Constipation Treatment questionnaire (satisfaction with treatment, willingness to re-use)
研究概览
简要总结
To determine whether female patients have a preference for tegaserod of PEG 3350 relative to dosage form, convenience, ease of administration and taste
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged 18 to 64 years of age
- •Patients with constipation as defined by the Rome II criteria
排除标准
- •Patients who have been previously been treated with tegaserod and/or PEG 3350
- •Evidence of cathartic colon or a history of laxative abuse or laxative dependence
- •History of fecal impaction which necessitated surgical intervention
- •Patients with clinically significant abnormal TSH levels at screening
- •Women who are pregnant or breast feeding
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
To determine after 14 / 35 days of treatment if women with constipation have a preference for tegaserod compared to PEG 3350, based on the assessment of the Constipation Treatment questionnaire (satisfaction with treatment, willingness to re-use)
次要结局
未报告次要终点
研究者
研究点 (28)
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