Constipation
Conditions
Keywords
constipation, pediatric
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.
Interventions
DRUGMiraLax
Sponsors
Braintree Laboratories
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female constipated outpatients between the ages of 4 and 16 2. Currently taking a dose of less than or equal to 17g of PEG 3350 powder that has been consistent for at least 4 weeks 3. Current treatment is considered successful - defined as greater than 2 bowel movements per week with no accidents 4. Are otherwise in good health, as judged by a physical examination 5. 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 6. In the investigator's judgment, patient or guardian is mentally competent to sign an instrument of informed consent
Exclusion criteria
1. Patients with heme positive stool at baseline exam 2. Patients who are impacted at baseline exam 3. Patients that are not receiving PEG 3350 4. Patients on PEG 3350 that continue to have problems 5. Patients with known or suspected perforation or obstruction 6. Patients with a history of gastric retention, inflammatory bowel disease, bowel resection, or colostomy 7. Patients with a known history of organic cause for their constipation. 8. Patients currently using medications known to cause constipation. These include Opiates, antidepressants, SSRI's, antimotility agents and anticholinergics. 9. Patients who are breastfeeding, pregnant, or intend to become pregnant during the study 10. Female patients of childbearing potential who refuse a pregnancy test 11. Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedure 12. Patients with known allergy to PEG or PEG containing medications 13. 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 BM data. | — |
| Adverse events will be monitored and analyzed for safety purposes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient acceptance will be measured by analysis of subjective questionnaire data. | — |
Countries
United States
Outcome results
None listed