A Pilot Study of a New MiraLax® Dose Formulation For Use in Constipated Children

Study Overview
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Brief Summary
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To evaluate patient acceptance of a new MiraLax dose formulation in children currently treated with polyethylene glycol 3350 powder for treatment of constipation.

Detailed Description
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To evaluate patient acceptance of a new MiraLax dose formulation in children currently treated with polyethylene glycol 3350 powder for treatment of constipation.

Official Title
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A Pilot Study of a New MiraLax® Dose Formulation For Use in Constipated Children

Conditions
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Constipation

Intervention / Treatment
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* Drug: MiraLax


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MiraLax|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy will be measured by analysis of patient self-reported BM data. |  |  | 
| Adverse events will be monitored and analyzed for safety purposes. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient acceptance will be measured by analysis of subjective questionnaire data. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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constipation, pediatric