A Pilot Study of a New PEG3350 Dose Formulation For Use in Constipated Children

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the patient acceptance of a new PEG3350 dose formulation in children currently treated with PEG3350 powder for treatment of constipation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Braintree Laboratories
• Treatments: Polyethylene glycol 3350

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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