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Maintenance Treatment for Children With Constipation

This study has been completed.
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: August 4, 2016
Last verified: August 2016
Results First Received: August 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Constipation
Interventions: Drug: Polyethylene glycol 3350
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Active Maintenance Treatment 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.
Placebo Maintenance Treatment 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.

Participant Flow:   Overall Study
    Active Maintenance Treatment     Placebo Maintenance Treatment  
STARTED     49     53  
COMPLETED     47     48  
NOT COMPLETED     2     5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Active Maintenance Treatment 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.
Placebo Maintenance Treatment 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.
Total Total of all reporting groups

Baseline Measures
    Active Maintenance Treatment     Placebo Maintenance Treatment     Total  
Number of Participants  
[units: participants]
  49     53     102  
Age, Customized  
[units: years]
Median (Full Range)
  6.2  
  (2.5 to 12.3)  
  6.1  
  (2.0 to 15.1)  
  6.1  
  (2.0 to 15.1)  
Gender  
[units: participants]
     
Female     18     27     45  
Male     31     26     57  
Region of Enrollment  
[units: participants]
     
Denmark     49     53     102  



  Outcome Measures

1.  Primary:   Treatment Recovery   [ Time Frame: ½ year ]

2.  Secondary:   Usage of Laxative   [ Time Frame: ½ year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Line Modin
Organization: Pediatric Department, Hospital Lillebaelt, Kolding
phone: 0045 61386349
e-mail: line.modin@rsyd.dk



Responsible Party: Line Modin, Vejle Hospital
ClinicalTrials.gov Identifier: NCT01566409     History of Changes
Other Study ID Numbers: MainCon
Study First Received: March 27, 2012
Results First Received: August 4, 2016
Last Updated: August 4, 2016
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics