Status:
COMPLETED
A Pilot Study of a New MiraLax® Dose Formulation For Use in Constipated Children
Lead Sponsor:
Braintree Laboratories
Conditions:
Constipation
Eligibility:
All Genders
4-16 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00319670
Start Date
March 1 2006
Last Update
February 7 2013
Active Locations (2)
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1
Boston, Massachusetts, United States, 02115
2
Youngstown, Ohio, United States, 44514