Chronic Functional Constipation MedDRA version: 18.1 Level: LLT Classification code 10067374 Term: Stypsis System Organ Class: 100000004865
Conditions
Interventions
Trade Name: PAXABEL - 20 BUSTINE DI POLVERE PER SOLUZIONE ORALE DA 4 G
Product Name: Paxabel 4g
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: MACROGOL 4000
CAS Number: 25322-68-
Sponsors
ABOCA S.P.A. SOCIETà AGRICOLA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the performance, in terms of frequency of evacuations per week and in stool consistency,of the administration of evacuation enemas with Promelaxin® compared to Macrogol 4000 in the treatment of chronic constipation in infants aged between 6 and 24 months.;Secondary Objective: 1. To evaluate safety and tolerability of Promelaxin® administered by rectal route, in infants and children affected by chronic functional constipation. 2. To evaluate the effects of the use of Promelaxin® administered by rectal route versus Macrogol 4000 administered orally on the quality of life of parents of infants and children aged between 6 and 24 months, affected by chronic functional constipation. 3. To evaluate the changes of the intestinal microbiota induced by the use of Promelaxin® administered by rectal route versus Macrogol 4000 adminitered orally. ;Primary end point(s): Improvement of constipation evaluated as a reduction of the typical symptoms of chronic functional constipation.;Timepoint(s) of evaluation of this end point: Days: 14, 21 and 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 Score of the quality of life of parents calculated on day 21 and 56 2 Score of the quality of life of children calculated on day 21 and 56 3 Gastrointestinal symptoms in intfants on day 14, 21 and 56 4 Changes in the intestinal microbioma on day 21 and 56 5 Evaluation of the normalization of the intestinal activity measured by recording the frequency of evacuations and and stool consistency on day 14, 21 and 56 6 Products safety in terms of adverse events reported by parents / legal representative of the subject. ;Timepoint(s) of evaluation of this end point: 1 On day 21 and 56 2 On day 21 and 56 3 On day 14, 21 and 56 4 On day 21 and 56 5 On day 14, 21 and 56 6 On day 14, 21 and 56 | — |
Countries
Italy
Contacts
Public ContactServizio Segreteria Aboca
Aboca SpA Società Agricola
Outcome results
None listed