Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03177434
Recruitment Status : Unknown
Verified June 2017 by JAROSLAW KIERKUS, Children's Memorial Health Institute, Poland.
Recruitment status was:  Recruiting
First Posted : June 6, 2017
Last Update Posted : June 6, 2017
Sponsor:
Collaborators:
Medical University of Bialystok
University of Rzeszow
Information provided by (Responsible Party):
JAROSLAW KIERKUS, Children's Memorial Health Institute, Poland

Tracking Information
First Submitted Date  ICMJE June 2, 2016
First Posted Date  ICMJE June 6, 2017
Last Update Posted Date June 6, 2017
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2017)
Assessment of efficacy of Dicopeg Junior, compared to lactulose, in the treatment of functional constipation in children aged 6 months to 6 years. [ Time Frame: 16 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Dicopeg Junior in Comparison With Lactulose for the Treatment of Functional Constipation in Children Aged 6 Months to 6 Years.
Official Title  ICMJE Multicenter Study Evaluating the Efficacy of Dicopeg Junior in Comparison With Lactulose for the Treatment of Functional Constipation in Children Aged 6 Months to 6 Years. A Prospective, Randomized Study.
Brief 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).
Detailed Description

Reason for study:

Defecation disorders, and among them constipation, are one of the most common gastrointestinal problems in children. According to data from the literature, the problem affects 1% - 7.5% of the children population who come to a general pediatrician, 25% of patients in gastroenterological practice, and even 45% in a highly specialized gastroenterology centers [1, 2]. In 17% - 40% of children with constipation symptoms begin in the first year of life [1]. The most common cause of chronic constipation in children are functional disorders, in approx. 90% of cases [3]. Essential to the diagnosis is to exclude anatomical abnormalities, neurological, endocrine and metabolic reasons, which can cause constipation, and declare at least two signs contained in the Rome III Criteria: 2 or less defecation during week, retention of large amount of fecal masses in the rectum; as well large stools which may clog the toilet [4]. The aim of treatment is to regulate bowel movements and prevent recurrence of symptoms. The mainstay of treatment is to change eating habits, defecation training and farmacotherapy with laxative drugs.

According to ESPGHAN / NASPGHAN guidelines, as first-line drugs are recommended polyethylene glycols (PEG) - 3350 or 4000, at a dose of 0.2 - 0.8 g/kg/day, and in case of unavailability or in children under 1 year of age recommends use of lactulose in a dose of 1 -3 ml/kg. Launch of preparation Dicopeg (polyethylene glycol 3350) - the first macrogol holding registration for the use of patients from 6 months of age, is giving greater therapeutic options for these patients.

In the literature, there are few reports on the use of polyethylene glycols in children. There is a need for controlled studies evaluating the efficacy and safety of use of polyethylene glycols in children, especially because that existing studies were conducted before the release of the current guidelines ESPGHAN / NASPGHAN [5].

AIM of the study:

Assessment of efficacy Dicopeg Junior for the treatment of functional constipation in children aged 6 months to 6 years.

Endpoints:

Primary 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.

Secondary Assessment of the side effects of treatment, such as abdominal pain, diarrhea, nausea, vomiting, bloating, gas, irritation of the anal area. In addition, the number of stools per week, defecation with pain during the week or hard, constipated stools.

Course of study:

Day 0- inclusion in the study (first visit). Data collection which are qualifying or disqualifying the child in participation in the study and examination of the child with evaluation of fecal retention.

After examination of the patient, according to the decision of the attending physician, performing or not rectal enema cleaning prior to randomization patient.

The signing of informed consent for participation in the study by the parents of children eligible to participate in the study. Establishment a patient card (attached).

Randomization to the group with Dicopeg Junior or lactulose (central randomization).

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).

Provide instructions concerning the use of the diary, defecation training and the use of fiber-rich diet. Issue diary, Bristol scale and test preparation.

Providing information about the possibility of telephone contact in case of diarrhea / excessive drug reaction / intolerance of the drug during the study to modify the dose.

4 weeks study Telephone consultation (on day 28 of the study) in order to monitor the status of the child, the effectiveness of treatment (number of completions stools per week, abdominal pain during defecation, stool consistency), the evaluation of side effects, discuss the entries in the diary, additional recommendations. The visit will be recorded on the patient card.

In the case of registration of intolerance or lack of efficacy of lactulose (the patient still meets the criteria Roman) in the second group it will be proposed to the patient treatment with Dicopeg Junior in accordance with the dosage in the first group to complete the 12 week study. Then the patient will be asked to come to the medical cenetr the next day, ie. in a 29 day study after receiving the preparation Lactulose.

The final 12 weeks study visit in order to evaluate the effectiveness of treatment, a summary of recommendations, assessment of adverse events and return the diary. Conducting examination. Note in the patient's diary visit.

Follow up- 16 weeks study Telephone contact to assess the state of the child, the amount of completions stools per week, abdominal pain during defecation, stool consistency, issue additional recommendations. If necessary, establish a child visits the clinic Gastrological. Note in the patient's visit.

Diary:

The table where the parent of a child writes the application preparation (Dicopeg Junior or Lactulose), the number of cast stools, their consistency, the occurrence of pain during defecation, encopresis and adverse events.

Duration:

12 weeks + 4 weeks follow-up (follow-up).

The study population. Statistics. Children aged 6 months to 6 years, fulfilling the inclusion criteria, sample size 102 patients (determined on the basis of the statistical program, taking into account the difference in the groups 30%) Assuming the difference between the groups in terms of achieving a therapeutic effect of 30%: the success of treatment group- 60% success in the control group 30%, at a power of 0.8 and assuming the test discontinuation by 20% of children final calculation of the required number of patients is 102 patients .

Assuming the difference between the groups in terms of achieving a therapeutic effect of 30%: the success of treatment group-60% success in the control group 30%, at a power of 0.8 and assuming the test discontinuation by 20% of children final calculation of the required number of patients is 102 patients .

The number of patients:

The probability of therapeutic success in the control group = 0.3 The probability of therapeutic success in test group = 0.6

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Constipation
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Dicopeg Junior

    Polyethylene glycols (PEG) - 3350 Dosage form: oral solution sachets Frequency: 2 doses

    Dosage:

    • 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, Duration: 12 weeks vs Lactulose Dosage form: oral solution Dosage: 2 ml / kg / day Frequency: 2 doses Duration: 12 weeks
    Intervention: Drug: polyethylene glycols (PEG) 3350
  • Active Comparator: Lactulose
    Lactulose Dosage form: oral solution Dosage: 2 ml / kg / day Frequency: 2 doses Duration: 12 weeks
    Intervention: Drug: Lactulose Oral Product
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 4, 2017)
102
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2018
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Children aged 6 months - 6 years
  2. Diagnosis of functional constipation according to the Rome III criteria
  3. Patients newly recognized or ineffectively treated
  4. Parental consent for their child's participation in the study and the way they are treatment for the duration of the study

Exclusion Criteria:

  1. Well-known organic cause constipation (eg. an underactive thyroid, Hirschprung disease, cystic fibrosis).
  2. Anatomical abnormality of the digestive tract.
  3. Status after gastrointestinal surgery
  4. Parents disagree to participate in the study
  5. Intolerance of lactulose or polyethylene glycols in an interview
  6. Comorbidities that may significantly affect the treatment outcome: food allergy, celiac disease, CNS disease, lactose intolerance or other disaccharide bacterial overgrowth
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03177434
Other Study ID Numbers  ICMJE IPCZD 27.01.2016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: publication
Responsible Party JAROSLAW KIERKUS, Children's Memorial Health Institute, Poland
Study Sponsor  ICMJE Children's Memorial Health Institute, Poland
Collaborators  ICMJE
  • Medical University of Bialystok
  • University of Rzeszow
Investigators  ICMJE Not Provided
PRS Account Children's Memorial Health Institute, Poland
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP