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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00319670
• Other study ID #: 851-201
• Status: Completed
• Phase: Phase 4
• First received: April 27, 2006
• Last updated: February 6, 2013
• Start date: March 2006

Study information

• Verified date: February 2013
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate patient acceptance of a new MiraLax dose formulation in children currently treated with polyethylene glycol 3350 powder for treatment of constipation.

Description:

To evaluate patient acceptance of a new MiraLax dose formulation in children currently treated with polyethylene glycol 3350 powder for treatment of constipation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 16 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• MiraLax

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy will be measured by analysis of patient self-reported BM data.
Primary	Adverse events will be monitored and analyzed for safety purposes.
Secondary	Patient acceptance will be measured by analysis of subjective questionnaire data.