constipation MedDRA version: 12.1 Level: LLT Classification code 10010774 Term: Constipation
Conditions
Interventions
Trade Name: MOVICOL
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: SODIO BICARBONATO
CAS Number: 144-55-8
Concentration type: equal
INN or Proposed INN: SODIO CLORURO
CAS Number: 7
Sponsors
UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 6 months-18 years Diagnosis of functional constipation according to the criteria of Rome III No therapy rammollitori faecal must have been started during the week before the start of the study All parents or their guardians must sign a document of informed consent indicating their awareness of nature investigazionale and risks of this study. Compliance with the study protocol Are the trial subjects under 18? yes Number of subjects for this age range: 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
Exclusion criteria
Exclusion criteria: Inability or unwillingness to give informed consent; Diagnosis of constipation of organic nature; Persons who use or have used in previous 7 days of faecal rammollitori; Delayed emission of meconium in the newborn at term; Presence of any other significant medical condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare Movicol 3350 (Polyethyleneglycol with electrolytes) with SedaStip (acacia fiber, psyllium fiber (Plantago ovata), fructose) in the treatment of Chronic Functional Constipation in childhood.;Secondary Objective: Evaluate the clinical efficacy and side effects of Movicol 3350 (Polyethyleneglycol with electrolytes).;Primary end point(s): constipation | — |
Countries
Italy
Outcome results
None listed