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

• Status: Completed
• Trial end date: 2020-03-17
• Target enrollment: 0
• Participant gender: All

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-

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aboca Spa Societa' Agricola
• Collaborators: Ceinge - Biotecnologie Avanzate s.c. a r.l.; Eclisse - Euromed Clinical Supply Services Srl; Latis S.r.l.; PhAST Consulting Srl

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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