Constipation
Conditions
Brief summary
To evaluate the patient acceptance of a new PEG3350 dose formulation in children currently treated with PEG3350 powder for treatment of constipation.
Interventions
DRUGPEG3350
PEG3350
Sponsors
Braintree Laboratories
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy will be measured by analysis of patient self reported bowel movement (BM) data | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | 2 weeks |
Countries
United States
Outcome results
None listed