Assessment of Elemental Impurities Level After Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
研究概览
简要总结
The main purpose of this study is to assess the concentration of elemental impurities in blood and urine after chronic administration of Smecta® in subjects with chronic functional diarrhoea. For exploratory purposes, the potential effects of diosmectite on bowel microbiote composition will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, between 18 and 60 years old inclusive, BMI between 19 and 32 kg/m2 inclusive (minimum body weight of 50 kg at screening).
- •Functional chronic diarrhoea defined as loose or watery stools occurring in at least 75% of stools for the last 3 months (with symptom onset at least 6 months before diagnosis).
排除标准
- •No history of suspected organic or drug induced cause to chronic diarrhoea.
研究组 & 干预措施
Diosmectite (Smecta®)
5 weeks of diosmectite 3g, 3 times daily.
干预措施: Diosmectite (Smecta®) (Drug)
结局指标
主要结局
Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period
时间窗: Screening and pre-dose Day -1 up to Day 125.
Baseline blood lead levels (BLL) were defined as the average between the available screening and pre-dose (Day-1) values. Values below the limit of detection (LOD) or below the lower limit of quantification (LLOQ) were replaced by LOD/2 or LLOQ/2 values. The absolute mean change from baseline in BLL during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning. The absolute mean change from baseline in BLL during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study).
次要结局
- Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period(Screening and pre-dose Day -1 up to Day 125.)
- Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period(Screening and pre-dose Day -1 up to Day 125.)
- Mean Change From Baseline in Urine Lead Levels During the Treatment Period and Post-treatment Follow-up Period(Screening and pre-dose Day -1 up to Day 95.)
- Mean Change From Baseline in Urine Cadmium Levels During the Treatment Period and Post-treatment Follow-up Period(Screening and pre-dose Day -1 up to Day 95.)
- Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period(Screening and pre-dose Day -1 up to Day 125.)
- Mean Change From Baseline in Urine Nickel Levels During the Treatment Period and Post-treatment Follow-up Period(Screening and pre-dose Day -1 up to Day 95.)
- Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period(Screening and pre-dose Day -1 up to Day 125.)
- Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period(Screening and pre-dose Day -1 up to Day 125.)
- Mean Change From Baseline in Urine Arsenic Levels During the Treatment Period and Post-treatment Follow-up Period(Screening and pre-dose Day -1 up to Day 95.)
- Mean Change From Baseline in Urine Barium Levels During the Treatment Period and Post-treatment Follow-up Period(Screening and pre-dose Day -1 up to Day 95.)
- Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period(Screening and pre-dose Day -1 up to Day 125.)
- Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period(Screening and pre-dose Day -1 up to Day 125.)
- Mean Change From Baseline in Urine Aluminium Levels During the Treatment Period and Post-treatment Follow-up Period(Screening and pre-dose Day -1 up to Day 95.)
- Mean Change From Baseline in Urine Cobalt Levels During the Treatment Period and Post-treatment Follow-up Period(Screening and pre-dose Day -1 up to Day 95.)
- Mean Change From Baseline in Urine Mercury Levels During the Treatment Period and Post-treatment Follow-up Period(Screening and pre-dose Day -1 up to Day 95.)