NCT02751411

Effectiveness & Safety of Promelaxin® Microenemas Against Macrogol 4000 P.O. in Chronic Constipation in Children 6-48 Months

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Aboca Spa Societa' Agricola · Industry
• Sex: All
• Age: 6 Months – 48 Months
• Healthy volunteers: Not accepted

Summary

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-

Detailed description

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.

Conditions

• Chronic Functional Constipation

Interventions

Type	Name	Description
DEVICE	micro-enema with Promelaxin	The intervention has a lubricating, protective action on the anus and rectum and a balanced osmotic action which elicits the evacuation reflex.
DRUG	Macrogol 4000	Stool softener

Timeline

• Start date: 2016-04-18
• Primary completion: 2019-12-31
• Completion: 2020-03-17
• First posted: 2016-04-26
• Last updated: 2020-05-29

Locations

4 sites across 1 country: Italy