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

Primary Purpose

Constipation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
MiraLax
Sponsored by
Braintree Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring constipation, pediatric

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

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

Patient acceptance will be measured by analysis of subjective questionnaire data.

Full Information

First Posted
April 27, 2006
Last Updated
February 6, 2013
Sponsor
Braintree Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00319670
Brief Title
A Pilot Study of a New MiraLax® Dose Formulation For Use in Constipated Children
Official Title
A Pilot Study of a New MiraLax® Dose Formulation For Use in Constipated Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Braintree Laboratories

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
constipation, pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
MiraLax
Primary Outcome Measure Information:
Title
Efficacy will be measured by analysis of patient self-reported BM data.
Title
Adverse events will be monitored and analyzed for safety purposes.
Secondary Outcome Measure Information:
Title
Patient acceptance will be measured by analysis of subjective questionnaire data.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Nurko, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44514
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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