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

February 6, 2013 updated by: Braintree Laboratories
To evaluate patient acceptance of a new MiraLax dose formulation in children currently treated with polyethylene glycol 3350 powder for treatment of constipation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • Ohio
      • Youngstown, Ohio, United States, 44514

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy will be measured by analysis of patient self-reported BM data.
Adverse events will be monitored and analyzed for safety purposes.

Secondary Outcome Measures

Outcome Measure
Patient acceptance will be measured by analysis of subjective questionnaire data.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Braintree Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

April 27, 2006

First Submitted That Met QC Criteria

April 27, 2006

First Posted (Estimate)

April 27, 2006

Study Record Updates

Last Update Posted (Estimate)

February 7, 2013

Last Update Submitted That Met QC Criteria

February 6, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 851-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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