Trial record 7 of 103 for:    Open Studies | "Constipation"

Maintenance Treatment for Children With Constipation

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Vejle Hospital
Sponsor:
Collaborators:
University of Southern Denmark
Kolding Sygehus
Information provided by (Responsible Party):
Line Modin, Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01566409
First received: March 27, 2012
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

Constipation is a common problem among children. The majority of children suffering from constipation have no underlying disease. Although constipation has no basis in underlying disease, it often leads to a reduced quality of life of children who are on par with or worse than for children suffering from serious diseases such as cardiovascular and rheumatic diseases.

Despite the high frequency of constipation among children, little is known about the causes and treatment of constipation.

Treatment consists of symptomatic treatment with various laxatives. Movicol and Movicol junior has proven very effective and are therefore widely used in children as disimpaction and maintenance treatment. There is currently no research to prove the need for and length of maintenance treatment with laxative medications in children.

The purpose is to examining the effectiveness of maintenance treatment with Movicol. Additional til study will examine how the anal diameter change during a course of treatment and the degree to which it can be used as an indicator of treatment efficacy.

The study will test the following:

• What is the effect of maintenance treatment with PEG compared to placebo?

The results from this study are expected to form the basis for an evidence-based approach to the use of maintenance therapy and the use of ultrasound of the rectum in children with constipation.


Condition Intervention
Constipation
Drug: Polyethylene glycol 3350
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Maintenance Treatment With Polyethylene Glycol 3350 for Children With Constipation. A Randomized, Placebocontrolled Intervention Study

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Treatment recovery [ Time Frame: ½ year ] [ Designated as safety issue: No ]
    Recovery is defined as the child having no symptoms of constipation according to the Rome III criteria.


Secondary Outcome Measures:
  • Usage of laxative [ Time Frame: ½ year ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: September 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active maintenance treatment Drug: Polyethylene glycol 3350
Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
Other Names:
  • Movicol
  • Movicol junior
  • Moxalole
  • Lacrofarm
Placebo Comparator: Placebo maintenance treatment Other: Placebo
Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children between 2 and 16 years and referral to our out patient clinic with either constipation or fecal incontinence.
  • Patients must fulfill the Rome III criteria of constipation, which mean they must have at least 2 of the following characteristics: fewer than 3 bowel movements weekly, more than 1 episode of fecal incontinence weekly, large stools in the rectum by digital rectal examination or palpable on abdominal examination, occasional passing of large stools, display of retentive posturing and withholding behavior, and painful defecation.

Exclusion Criteria:

  • Children with known organic causes of constipation, including Hirsprung disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases.
  • Children receiving drugs known to affect bowel function during a 2 month period before initiation.
  • The healthy control group consists of children with no history of constipation (Rome III), urinary incontinence, urinary tract infections, fecal incontinence, laxative use or any other disease affecting the digestive system.
  • Children receiving medications known to affect bowel function are excluded from the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566409

Locations
Denmark
Line Modin Recruiting
Kolding, Denmark, 6000
Contact: Line Modin, MD    61-386349    line.modin@slb.regionsyddanmark.dk   
Sponsors and Collaborators
Line Modin
University of Southern Denmark
Kolding Sygehus
  More Information

No publications provided

Responsible Party: Line Modin, Medical doctor, Vejle Hospital
ClinicalTrials.gov Identifier: NCT01566409     History of Changes
Other Study ID Numbers: MainCon
Study First Received: March 27, 2012
Last Updated: March 19, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Vejle Hospital:
Constipation
Maintenance treatment
Ultrasound of rectum

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014