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

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)

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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