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CompletedNCT00319670Updated Feb 7, 2013

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

A Phase 4 interventional study of MiraLax in Constipation, sponsored by Braintree Laboratories. Completed at 2 sites in United States. Open to participants aged 4 Years to 16 Years. Per ClinicalTrials.gov, last updated 2013-02-07.

Sponsored by Braintree Laboratories · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
4 Years to 16 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Constipation

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Keywords

  • constipation
  • pediatric
03

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's enrollment of 25 is below the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Braintree Laboratories is the lead sponsor of 47 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants

Interventions

  • DrugMiraLax
06

What researchers measure

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.

07

Study locations

2 sites
  • Boston, Massachusetts 02115, United States
  • Youngstown, Ohio 44514, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00319670
Lead sponsor
Braintree Laboratories
First posted
Apr 27, 2006
Start date
Mar 2006
Primary completion
May 2006
Last update
Feb 7, 2013

Study contacts

Samuel Nurko, MD
principal investigator · Boston Children's Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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