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

NCT ID: NCT00319670

Last Updated: 2013-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31

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.

Conditions

Constipation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

MiraLax

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Braintree Laboratories

INDUSTRY

Sponsor Role: lead

Principal Investigators

Samuel Nurko, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston, Massachusetts, United States

Youngstown, Ohio, United States

Countries

United States

Other Identifiers

851-201

Identifier Type: -

Identifier Source: org_study_id