NCT00891371已完成2 期
A Phase II-III, Multicentre, Prospective, Exploratory, Open Label Study to Assess the Efficacy and Safety of Lanreotide Autogel 120mg in the Symptomatic Treatment of Patients With Refractory Diarrhea
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 42
- 试验地点
- 11
- 主要终点
- Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/24hours) in the Mean Number of Stools (Mean of Last 7 Days)
研究概览
简要总结
The purpose of this study, is to assess the effect of lanreotide Autogel 120mg on stool frequency in subjects with refractory diarrhea at day 28 (mean of last 7 days) compared to baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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/female with refractory diarrhea for at least 1 month, after normal extended work-up to exclude causes of diarrhea, not or not enough responding to standard anti-diuretics as evaluated by the investigator
- •Patient mentally fit for completing a diary
排除标准
- •Has already received a treatment with somatostatin analogues for the treatment of refractory diarrhea
- •Had a weight of stool < 600g in a 72hrs stool collection
- •Has received a treatment with laxatives within the last week before study entry
- •Suffers from IBS with alternating bowel habits and predominant constipation, suffers from infectious and/or inflammatory gastro-enteritis (colitis ulcerosa, crohn's disease and macroscopic colitis)
研究组 & 干预措施
lanreotide (Autogel formulation) Autogel 120mg
Experimental
lanreotide (Autogel formulation) Autogel 120mg
干预措施: lanreotide (Autogel formulation) (Drug)
结局指标
主要结局
Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/24hours) in the Mean Number of Stools (Mean of Last 7 Days)
时间窗: Day 28
次要结局
- Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline(Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56)
- Percent Change in Mean Number of Stools Compared to Baseline(Baseline (Day 1), Day 28 and Day 56)
- Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools(Day 56)
- Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline(Baseline (day 1), day 28 and day 56)
- Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects(Baseline (Day 1), Day 28 and Day 56)
研究者
研究点 (11)
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