A Pilot Study of a New PEG3350 Dose Formulation For Use in Constipated Children
Completed · Phase 4
Conditions studied: Constipation
In brief
To evaluate the patient acceptance of a new PEG3350 dose formulation in children currently treated with PEG3350 powder for treatment of constipation.
Key facts
- Study ID
- NCT00583609
- Run by
- Braintree Laboratories
- People needed
- 20
- Starts
- 2007-09-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2009-09-28
Who can join
Age: 4 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female constipated outpatients between the ages of 4 and 16
- Currently taking a dose of PEG 3350 powder up to a maximum of 17g per day that has been consistent for at least 4 weeks, or if less than 4 weeks, the investigator testifies that the patient is stable
- 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 for the duration of the 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 who are impacted at baseline exam
- 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
Where it is running
- Study site — Little Rock, Arkansas, United States
- Study site — Morristown, New Jersey, United States
Full record on ClinicalTrials.gov
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