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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-18

Study Completion Date

2020-03-17

Brief Summary

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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-

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Detailed Description

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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.

Conditions

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Chronic Functional Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized between two treatment arms

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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micro-enema with Promelaxin

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

Group Type EXPERIMENTAL

micro-enema with Promelaxin

Intervention Type DEVICE

The intervention has a lubricating, protective action on the anus and rectum and a balanced osmotic action which elicits the evacuation reflex.

Macrogol 4000

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).

Group Type ACTIVE_COMPARATOR

Macrogol 4000

Intervention Type DRUG

Stool softener

Interventions

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micro-enema with Promelaxin

The intervention has a lubricating, protective action on the anus and rectum and a balanced osmotic action which elicits the evacuation reflex.

Intervention Type DEVICE

Macrogol 4000

Stool softener

Intervention Type DRUG

Other Intervention Names

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Melilax Paxabel

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No