A Pilot Study of a New MiraLax® Dose Formulation For Use in Constipated Children
1 other identifier
interventional
25
1 country
2
Brief Summary
To evaluate patient acceptance of a new MiraLax dose formulation in children currently treated with polyethylene glycol 3350 powder for treatment of constipation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 27, 2006
CompletedFirst Posted
Study publicly available on registry
April 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedFebruary 7, 2013
February 1, 2013
2 months
April 27, 2006
February 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Efficacy will be measured by analysis of patient self-reported BM data.
Adverse events will be monitored and analyzed for safety purposes.
Secondary Outcomes (1)
Patient acceptance will be measured by analysis of subjective questionnaire data.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female constipated outpatients between the ages of 4 and 16
- Currently taking a dose of less than or equal to 17g of PEG 3350 powder that has been consistent for at least 4 weeks
- Current treatment is considered successful - defined as greater than 2 bowel movements per week with no accidents
- Are otherwise in good health, as judged by a physical examination
- If female and of childbearing potential, patient must be using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so during the duration of study
- In the investigator's judgment, patient or guardian is mentally competent to sign an instrument of informed consent
You may not qualify if:
- Patients with heme positive stool at baseline exam
- Patients who are impacted at baseline exam
- Patients that are not receiving PEG 3350
- Patients on PEG 3350 that continue to have problems
- Patients with known or suspected perforation or obstruction
- Patients with a history of gastric retention, inflammatory bowel disease, bowel resection, or colostomy
- Patients with a known history of organic cause for their constipation.
- Patients currently using medications known to cause constipation. These include Opiates, antidepressants, SSRI's, antimotility agents and anticholinergics.
- Patients who are breastfeeding, pregnant, or intend to become pregnant during the study
- Female patients of childbearing potential who refuse a pregnancy test
- Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedure
- Patients with known allergy to PEG or PEG containing medications
- Patients who, within the past 30 days have participated in an investigational clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Boston, Massachusetts, 02115, United States
Unknown Facility
Youngstown, Ohio, 44514, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel Nurko, MD
Boston Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 27, 2006
First Posted
April 27, 2006
Study Start
March 1, 2006
Primary Completion
May 1, 2006
Last Updated
February 7, 2013
Record last verified: 2013-02