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| Tracking Information | |||||
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| First Received Date ICMJE | April 26, 2007 | ||||
| Last Updated Date | April 27, 2007 | ||||
| Start Date ICMJE | December 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
To compare the efficacy of milk and molasses enema vs. PEG 3350 for global improvement of symptoms in children with fecal impaction and constipation [ Time Frame: two years ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00467350 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison Trial of Enema vs. PEG 3350 for Constipation | ||||
| Official Title ICMJE | Randomized Clinical Trial of Milk and Molasses Enema vs. PEG 3350 for Fecal Impaction in Childhood Constipation | ||||
| Brief Summary | The purpose of this study is to determine if milk and molasses enema or PEG 3350 works better for treatment of fecal impaction in children who are constipated. |
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| Detailed Description | Constipation is a common condition in childhood and occurs without evidence of a pathological condition in most children. Symptoms range from decreased appetite to abdominal pain and constipation is frequently diagnosed in children evaluated in emergency departments. A general guideline for constipation treatment is fecal impaction removal before initiation of maintenance therapy. Disimpaction may be achieved using various oral therapies (e.g. including Polyethylene Glycol 3350 or PEG); however, rectal therapies, most commonly enemas, are frequently used, especially in the emergency/urgent care setting. The optimal treatment has not been established. There are no published randomized studies that compare effectiveness of oral versus rectal treatments. Comparison: One milk and molasses enema given to the patient in the emergency department compared to three oral doses of PEG 3350 for relief of symptoms due to fecal impaction and constipation. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Constipation | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 140 | ||||
| Estimated Completion Date | December 2008 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 1 Year to 17 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00467350 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 06-07-117 | ||||
| Study Sponsor ICMJE | Children's Mercy Hospital Kansas City | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Children's Mercy Hospital Kansas City | ||||
| Verification Date | April 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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