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

This study has been completed.
Sponsor:
Information provided by:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00319670
First received: April 27, 2006
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Constipation
Drug: MiraLax
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of a New MiraLax® Dose Formulation For Use in Constipated Children

Resource links provided by NLM:


Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:
  • 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:
  • Patient acceptance will be measured by analysis of subjective questionnaire data.

Estimated Enrollment: 25
Study Start Date: March 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319670

Locations
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Ohio
Youngstown, Ohio, United States, 44514
Sponsors and Collaborators
Braintree Laboratories
Investigators
Principal Investigator: Samuel Nurko, MD Children's Hospital Boston
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00319670     History of Changes
Other Study ID Numbers: 851-201
Study First Received: April 27, 2006
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Braintree Laboratories:
constipation
pediatric

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014