A Pilot Study of a New MiraLax® Dose Formulation For Use in Constipated Children
Information source: Braintree Laboratories
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Constipation
Intervention: MiraLax (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Braintree Laboratories Official(s) and/or principal investigator(s):
Samuel Nurko, MD, Principal Investigator, Affiliation: Children's Hospital Boston
Summary
To evaluate patient acceptance of a new MiraLax dose formulation in children currently
treated with polyethylene glycol 3350 powder for treatment of constipation.
Clinical Details
Official title: A Pilot Study of a New MiraLax® Dose Formulation For Use in Constipated Children
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Efficacy will be measured by analysis of patient self-reported BM data.Adverse events will be monitored and analyzed for safety purposes.
Secondary outcome: Patient acceptance will be measured by analysis of subjective questionnaire data.
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.
Eligibility
Minimum age: 4 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male or female constipated outpatients between the ages of 4 and 16
2. Currently taking a dose of less than or equal to 17g of PEG 3350 powder that has been
consistent for at least 4 weeks
3. Current treatment is considered successful – defined as greater than 2 bowel movements
per week with no accidents
4. Are otherwise in good health, as judged by a physical examination
5. 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
6. In the investigator’s judgment, patient or guardian is mentally competent to sign an
instrument of informed consent
Exclusion Criteria:
1. Patients with heme positive stool at baseline exam
2. Patients who are impacted at baseline exam
3. Patients that are not receiving PEG 3350
4. Patients on PEG 3350 that continue to have problems
5. Patients with known or suspected perforation or obstruction
6. Patients with a history of gastric retention, inflammatory bowel disease, bowel
resection, or colostomy
7. Patients with a known history of organic cause for their constipation.
8. Patients currently using medications known to cause constipation. These include
Opiates, antidepressants, SSRI’s, antimotility agents and anticholinergics.
9. Patients who are breastfeeding, pregnant, or intend to become pregnant during the
study
10. Female patients of childbearing potential who refuse a pregnancy test
11. Patients who, in the opinion of the investigator, should not be included in the study
for any reason, including inability to follow study procedure
12. Patients with known allergy to PEG or PEG containing medications
13. Patients who, within the past 30 days have participated in an investigational clinical
study
Locations and Contacts
Boston, Massachusetts 02115, United States
Youngstown, Ohio 44514, United States
Additional Information
Starting date: March 2006
Last updated: June 6, 2006
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