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

A

Aboca

Status and phase

Completed
Phase 4

Conditions

Chronic Functional Constipation

Treatments

Device: micro-enema with Promelaxin
Drug: Macrogol 4000

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT02751411
ABO-MELI-15

Details and patient eligibility

About

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-

Full 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.

Enrollment

158 patients

Sex

All

Ages

6 to 48 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

158 participants in 2 patient groups

micro-enema with Promelaxin
Experimental group
Description:
2,5 g, 5 g or 2X5 g (calculated considering patient age) have to be administered daily (in the evening) for one week, once every other day for the second week and as needed for the following 6 weeks
Treatment:
Device: micro-enema with Promelaxin
Macrogol 4000
Active Comparator group
Description:
One/Two sachets of the study treatment has to be solubilized in 50mL of water and then administered daily. The administration should take place in the morning (the first sachet or in the event that only one sachet/day should be administered) and in the evening (second sachet).
Treatment:
Drug: Macrogol 4000

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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