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.

Phase 1

• Conditions: Chronic Functional Constipation; MedDRA version: 18.1Level: LLTClassification code 10067374Term: StypsisSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-005111-32-IT
• Lead Sponsor: ABOCA S.P.A. SOCIETà AGRICOLA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-04
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified