Multicenter, Prospective, Comparative, Randomized Controlled Clinical Trial to Evaluate the Performance and the Safety of Promelaxin® Micro-enemas Vs. Macrogol 4000 Per os in the Treatment of Functional Chronic Constipation in Children Aged Between 6 and 48 Months.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 4
- 主要终点
- Improvement of constipation evaluated as a reduction of the typical symptoms of chronic functional constipation
研究概览
简要总结
The study is aimed at the efficacy and safety evalutation of the study treatments through a 2-weeks study period and the subsequent follow-up-
详细描述
This multicenter, prospective, randomized, controlled trial will be conducted on 120 infants-children with a diagnosis of chronic functional constipation according to the definition of Criteria of Rome III. The enrolled subjects will be randomized according to an electronically generated randomization list in 2 groups: one group will receive micro-enemas of Promelaxin® (Group A) while the second group will receive Macrogol 4000 per os (Group B) . Children will receive the dedicated treatment for two weeks and then undergo a follow-up period of a maximun of 6 weeks.
The hypothesis is that the protective micro-enema will help achieving regular evacuation by its local antinflammatory non-pharmacological action. This hypothesis is based on the finding that local anal inflammation can cause functional constipation due to discomfort and pain during evacuation or by influencing reflexes.
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
- 6 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic functional constipation according to Rome III criteria
- •No stool softeners therapy administered during the 7 days prior to Baseline Visit
- •Signature of informed consent from by both parents or legal representative
- •Willingness to follow the study schedule
排除标准
- •Suspicious or established diagnosis of organic constipation
- •Delayed emission of meconium in the term newborn
- •Presence of severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease), toxic megacolon
- •Presence/Risk of gastroinstestinal perforation
- •Presence/Suspiceous intestinal obstruction of symptomatic stenosis
- •(Undeterminated) Abdominal pain
- •Hypersensitivity to macrogol (polyethylene glycol) or to one or more product excipients
- •Hereditary fructose intolerance
- •Known hypersensitivity or allergy to any Promelaxin component
- •Presence of any other medical condition that contraindicate the use of Promelaxin® or Macrogol 4000
研究组 & 干预措施
micro-enema with Promelaxin
2,5 g, 5 g or 2X5 g (calculated considering patient age) have to be administered daily (in the evening) for one week, once every other day for the second week and as needed for the following 6 weeks
干预措施: micro-enema with Promelaxin (Device)
Macrogol 4000
One/Two sachets of the study treatment has to be solubilized in 50mL of water and then administered daily. The administration should take place in the morning (the first sachet or in the event that only one sachet/day should be administered) and in the evening (second sachet).
干预措施: Macrogol 4000 (Drug)
结局指标
主要结局
Improvement of constipation evaluated as a reduction of the typical symptoms of chronic functional constipation
时间窗: day 14
Treatment should be considered as successful if the child will show, at Visit 3, 3 or more defecations per week associated with an increase of 1 or more defecations versus baseline.
次要结局
- score of the parents quality of life calculated on day 21 and 56(day 21 and day 56)
- score of the children quality of life calculated on day 21 and 56(day 21 and day 56)
- changes in the intestinal microbioma on day 21 and 56(day 21 and day 56)
- Gastrointestinal symptoms in children on days 14, 21 and 56(day 14, day 21 and day 56)
- Evaluation of the normalization of intestinal activity measured by recording frequency of evacuations and stool consistency on day 14, 21 and 56(day 14, day 21 and day 56)
- Change in stool consistency(day 14, day 21 and day 56)
- Product Safety(day 14, day 21 and day 56)