NCT01810653已完成4 期
A Double-blind, Randomized, Uninational, Multicenter, Two Parallel Groups, Active Controlled Study to Compare the Effect of the Treatment With Transipeg 2.95 g or Forlax Junior 4 g in Children With Constipation
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 97
- 主要终点
- Symptom Based Weekly Total Sum Score (TSS) Over 52 Weeks
研究概览
简要总结
The study design combines a long-term safety and a dose range determination objective. The first 8 weeks of the study were primarily intended for the dose range determination, while the later visits were used for the comparison of long-term safety between the groups.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Childhood functional constipation
- •6 months to <16 years of age
- •Male or female
- •For females of childbearing potential (after menarche): negative pregnancy test
- •Moderately severe to severe constipation, defined as stool frequency <3 stools/week
- •Informed consent signed by parent(s) or legal acceptable representative(s), after sufficient oral and written information before entering the study, to be documented by the investigators in the Case Report Form
排除标准
- •Functional non-retentive fecal incontinence
- •Known metabolic or endocrine disorders (s.a. hypothyroidism)
- •Neurologic disorders (s.a. spina bifida or spinal cord anomaly)
- •Hirschsprung's disease (congenital megacolon)
- •Anal anomaly
- •Gastrointestinal surgery
- •Drug induced constipation
- •Mental retardation
- •Cerebral palsy
- •Treatment with other laxatives
- •Drugs influencing gastrointestinal function (e.g., cisapride, erythromicin, imodium)
- •Prior bowel surgery, except appendectomy
- •Earlier participation in this trial
- •Concurrent participation in any other clinical trial
- •Participation in any other clinical study 6 months prior to inclusion
- •Any use of a Macrogol within 2 months prior to inclusion
研究组 & 干预措施
Macrogol (Transipeg)
Experimental
干预措施: Macrogol (Transipeg, BAY81-8430) (Drug)
Macrogol (Forlax)
Active Comparator
干预措施: Macrogol (Forlax) (Drug)
结局指标
主要结局
Symptom Based Weekly Total Sum Score (TSS) Over 52 Weeks
时间窗: Baseline (Week 0), Week 1, 2, 3, 4, 8, 12, 26, 52
Change From Baseline in Total Sum Score (TSS) at Week 52
时间窗: Baseline, Week 52
Short Term Change of Total Sum Score (TSS): Average of Weeks 1 to 8 Minus Baseline
时间窗: Average of Weeks 1 to 8
Long Term Change of Total Sum Score (TSS): Average of Weeks 26 and 52 Minus Baseline
时间窗: Average of Weeks 26 and 52
Overall Change of Total Sum Score (TSS): Average of all Diaries Obtained Minus Baseline
时间窗: Average up to 52 weeks
Dose Range Determination: Mean Dose Based on Sachets Used
时间窗: Up to 52 weeks.
Dose Range Determination: Mean Dose per Kilogram Body Weight Based on Sachets Used
时间窗: Up to 52 weeks
次要结局
- Percentage of Treatment Success(Week 1, 2, 4, 8, 12, 26, 52)
- Individual Symptoms: Defecation Frequency(Week 1, 2, 4, 8, 12, 26, 52)
- Individual Symptoms: Consistency of the Feces(Week 1, 2, 4, 8, 12, 26, 52)
- Individual Symptoms: Strains During Defecation(Week 1, 2, 4, 8, 12, 26, 52)
- Individual Symptoms: Quantity of Stools(Week 1, 2, 4, 8, 12, 26, 52)
- Individual Symptoms: Percentage of Subjects With Pain During Defecation(Week 1, 2, 4, 8, 12, 26, 52)
- Individual Symptoms: Frequency of Pain (Times per Week)(Week 1, 2, 4, 8, 12, 26, 52)
- Percentage of Subjects With Abdominal Pain(Week 1, 2, 4, 8, 12, 26, 52)
- Individual Symptoms: Frequency of Abdominal Pain (Times per Week)(Week 1, 2, 4, 8, 12, 26, 52)
- Individual Symptoms: Relation of Abdominal Pain With Defecation(Week 1, 2, 4, 8, 12, 26, 52)
- Individual Symptoms: Fecal Incontinence (Times per Week) and Fecal Incontinence (Times per Week) at Night(Week 1, 2, 4, 8, 12, 26, 52)
- Individual Symptoms: Percentage of Subjects with Fecal Incontinence at Specified Time points(Week 1, 2, 4, 8, 12, 26, 52)
- Individual Symptoms: Percentage of Subjects With Urgency for Defecation(Week 1, 2, 4, 8, 12, 26, 52)
- Individual Symptoms: Frequency of Urgency for Defecation (Times per Week)(Week 1, 2, 4, 8, 12, 26, 52)
- Individual Symptoms: Percentage of Subjects With Urine Incontinence (UI) During Day and Night(Week 1, 2, 4, 8, 12, 26, 52)
- Individual Symptoms: Frequency of Urine Incontinence During Day and Night (Times per Week)(Week 1, 2, 4, 8, 12, 26, 52)
- Individual Symptoms: Percentage of Subjects With Good, Moderate or Bad Appetite(Week 1, 2, 4, 8, 12, 26, 52)
- Individual Symptoms: Average Score for Diary Reported Diarrhoea(Week 0, 1, 2, 4, 8, 12, 26, 52)
- Individual Symptoms: Average Score for Diary Reported Flatulence(Week 0, 1, 2, 4, 8, 12, 26, 52)
- Individual Symptoms: Average Score for Diary Reported Nausea(Week 0, 1, 2, 4, 8, 12, 26, 52)
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