NCT01404923已完成4 期
Assessment of On-demand MeteoSpasmyl® Use Effectiveness in Irritable Bowel Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 436
- 主要终点
- Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score
研究概览
简要总结
The purpose of this study is to compare the effectiveness of 2 IBS treatment strategies:
- Strategy A = MeteoSpasmyl®, on-demand therapy
- Strategy B = standard of care chosen by the physician
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
- None
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 or female ambulatory patients, aged >= 18 years
- •with IBS as defined by Rome III criteria for more than 1 year and less than 10 years
- •with a IBS-SSS between 175 and 400
排除标准
- •Acute diarrhea, bowel disorders due to an underlying cause
- •Patient treated with MeteoSpasmyl® within the past 6 months
- •Recent history of gastro intestinal surgery
研究组 & 干预措施
meteospasmyl
Experimental
干预措施: alverine citrate, simeticone (Drug)
standard of care
Active Comparator
干预措施: anti spasmodic agents (Drug)
结局指标
主要结局
Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score
时间窗: Baseline and 6 months
Irritable Bowel Syndrome Quality of Life total score (IBSQoL) is a health-related Quality of Life (QoL) disease-specific scale adapted for French patients. Total score ranges from minimum=0 to maximum = 100 representing the best outcome.
Percentage of Improvement of the Total IBSQoL Scores
时间窗: Baseline and 6 Months
Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage
次要结局
未报告次要终点
研究者
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