Multicenter, Prospective, Comparative, Randomized Controlled Clinical investigation on the performance of Promelaxin® micro-enemas versus oral administration of Macrogol 4000, in the treatment of chronic constipation in infants aged between 6 and 24 months. - Not available

ABOCA S.P.A. SOCIETà AGRICOLA0 个研究点目标入组 120 人开始时间: 2016年4月4日最近更新: 2020年11月23日

适应症

试验速览

暂无简介。

•1. Age between 6 and 24 months
•2. Diagnosis of chronic functional constipation according to the Roma III criteria (Appendix 3)
•3. No theraphy with fecal softener within 7 days before the start of the study.
•4. Informed consent signed by both parents or legal representative, indicating awareness of the investigational nature and of the risks of the study
•5. Parents willing and able to attend the scheduled study visits , to fill in the diary and to follow the instructions of the Investigator
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 120
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Suspicious or diagnosed constipation of organic nature
•2. Delayed emission of meconium in the term newborn
•3. Presence of severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease), toxic megacolon
•4. Presence of digestive perforation or risk of digestive perforation
•5. Presence of Ileus or suspicion of intestinal obstruction
•6. Presence of painful abdominal syndromes of indeterminate cause
•7. Hypersensitivity to macrogol (polyethylene glycol)or to any of the excipients
•8. Hereditary problems of fructose intolerance
•9. Known hypersensitivity or allergy to any component of Promelaxin
•10. Presence of any other medical condition that contraindicates the use of Promelaxin® or Macrogol 4000

发起方