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OpenTrials
Completed

NCT Number: NCT00319670

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

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

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Boston, Massachusetts, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female constipated outpatients between the ages of 4 and 16
  • Currently taking a dose of less than or equal to 17g of PEG 3350 powder that has been consistent for at least 4 weeks
  • Current treatment is considered successful - defined as greater than 2 bowel movements per week with no accidents
  • Are otherwise in good health, as judged by a physical examination
  • 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
  • In the investigator's judgment, patient or guardian is mentally competent to sign an instrument of informed consent

Exclusion criteria

  • Patients with heme positive stool at baseline exam
  • Patients who are impacted at baseline exam
  • Patients that are not receiving PEG 3350
  • Patients on PEG 3350 that continue to have problems
  • Patients with known or suspected perforation or obstruction
  • Patients with a history of gastric retention, inflammatory bowel disease, bowel resection, or colostomy
  • Patients with a known history of organic cause for their constipation.
  • Patients currently using medications known to cause constipation. These include Opiates, antidepressants, SSRI's, antimotility agents and anticholinergics.
  • Patients who are breastfeeding, pregnant, or intend to become pregnant during the study
  • Female patients of childbearing potential who refuse a pregnancy test
  • Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedure
  • Patients with known allergy to PEG or PEG containing medications
  • Patients who, within the past 30 days have participated in an investigational clinical study

Treatment and study plan

MIRALAX

Drug

Primary outcomes

  1. Efficacy will be measured by analysis of patient self-reported BM data.

  2. Adverse events will be monitored and analyzed for safety purposes.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Braintree Laboratories

Industry

Registry information

Important dates

Study start
2006
Primary completion
2006
First posted
Apr 27, 2006
Registry last updated
Feb 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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