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

Braintree Laboratories

Status and phase

Completed

Phase 4

Conditions

Constipation

Treatments

Drug: PEG3350

Study type

Interventional

Funder types

Industry

Identifiers

851-PP-03

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

4 to 16 years old

Volunteers

No Healthy Volunteers

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