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Efficacy of Dicopeg Junior in Comparison With Lactulose for the Treatment of Functional Constipation in Children Aged 6 Months to 6 Years.

NCT03177434 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2017-06-06

No results posted yet for this study

Summary

Assessment of efficacy of Dicopeg Junior, compared to lactulose, in the treatment of functional constipation in children aged 6 months to 6 years. The basis of assessment is to compare the number of commissioned stools (more than three stools per week) and stool consistency according to the scale of Bristol, in children taking Dicopeg Junior and children treated with lactulose. Childrens who meet the inclusion criteria will be randomized to one of two groups, in which the treatment will be as follows for 12 weeks:

1. The first group - Dicopeg Junior (max. in 2 doses) in a dose of:

* weight up to 8 kg - 1 sachet per day
* weight 8 - 12 kg - 2 sachets a day
* weight 12 - 20 kg - 3 sachets a day
* weight\> 20 kg - 4 sachets per day,
2. The second group - Lactulose at 2 ml / kg / day (in two doses). Preparations: Dicopeg Junior and Lactulose will be administered orally for the duration of the study (12 weeks).

Conditions

Interventions

DRUG

polyethylene glycols (PEG) 3350

Evaluating the efficacy of Dicopeg Junior in comparison with lactulose for the treatment of functional constipation in children aged 6 months to 6 years.

DRUG

Lactulose Oral Product

Evaluating the efficacy of Dicopeg Junior in comparison with lactulose for the treatment of functional constipation in children aged 6 months to 6 years.

Sponsors & Collaborators

  • Medical University of Bialystok

    collaborator OTHER

  • University of Rzeszow

    collaborator OTHER

  • Children's Memorial Health Institute, Poland

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03177434 on ClinicalTrials.gov