ConstipationPhase 4NCT00153114
PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children
A Phase 4 study testing polyethyleneglycol3350 in people with Constipation, run by Braintree Laboratories at 3 sites in United States.
Trial summary
Assess the safety and efficacy of polyethyleneglycol3350 laxative as compared to placebo therapy in pediatric patients with a history of constipation. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Constipation
- What is being tested?
- polyethyleneglycol3350
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2003to Sep 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- Child
Who may be able to join
- Male or female outpatients between the ages of 4 to 16 years.
- Adolescent female patients must not be pregnant or lactating.
- constipated according to ROME I definition
- Two or fewer bowel movements during the initial observation week.
- Absence of a stool impaction
- Bowel movement after receiving enema
- Are otherwise in good health, as judged by a physical examination.
- Parent or guardian is mentally competent to sign an instrument of informed consent
Who cannot join
- Patients with heme positive stool at baseline exam.
- Patients with fecal impaction at baseline, or after the observation period, as indicated by physical exam
- Patients with known or suspected perforation or obstruction other than fecal impaction.
- Patients who are breastfeeding, pregnant or intend to become pregnant during the study.
- Female patients of childbearing potential who refuse a pregnancy test.
- Patients with a known history of organic cause for their constipation.
Show all 13Show fewer
- Patients with congenital malformations that produce constipation (Hirschsprung's disease, imperforate anus, children with cerebral palsy or other neurologic abnormalities, or systemic diseases).
- History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy.
- Use of concomitant medications that cause constipation
- Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures.
- Patients with known allergy to polyethyleneglycol or polyethyleneglycol containing medications.
- Patients with clinically significant elevations of TSH or abnormal plasma electrolytes.
- Patients who, within the past 30 days have participated in an investigational clinical study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Boston, Massachusetts, 02115
Study site
Morristown, New Jersey, 07962
Study site
Pittsburgh, Pennsylvania, 15213
About this study
Assess the safety and efficacy of polyethyleneglycol3350 laxative as compared to placebo therapy in pediatric patients with a history of constipation.
- Conditions
- Constipation
- Being tested
- polyethyleneglycol3350
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethyleneglycol3350Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Greater than 2 bowel movements per week
Secondary outcomes (2)
Analysis of individual ROME I criteria
Safety (adverse event and laboratory testing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2003
- Primary completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Samuel Nurko, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153114
- Sponsor's protocol ID
- 851-15
- Status last verified
- Feb 2013
- First submitted
- 7 Sep 2005
- Last updated
- 7 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children
- ClinicalTrials.gov ID
- NCT00153114
- Acronym / sponsor ID
- 851-15
- Conditions
- Constipation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Sep 2004 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the safety and efficacy of polyethyleneglycol3350 laxative as compared to placebo therapy in pediatric patients with a history of constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (8 listed)
- Male or female outpatients between the ages of 4 to 16 years.
- Adolescent female patients must not be pregnant or lactating.
- constipated according to ROME I definition
- Two or fewer bowel movements during the initial observation week.
- Absence of a stool impaction
Key exclusion criteria (13 listed)
- Patients with heme positive stool at baseline exam.
- Patients with fecal impaction at baseline, or after the observation period, as indicated by physical exam
- Patients with known or suspected perforation or obstruction other than fecal impaction.
- Patients who are breastfeeding, pregnant or intend to become pregnant during the study.
- Female patients of childbearing potential who refuse a pregnancy test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polyethyleneglycol3350 | Drug | – |
Primary outcome
Greater than 2 bowel movements per week
2 secondary outcomes
Analysis of individual ROME I criteria
Safety (adverse event and laboratory testing)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Nurko, MD principal investigator
Boston Children's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing polyethyleneglycol3350 in people with Constipation, run by Braintree Laboratories at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Greater than 2 bowel movements per week. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2013; AzTrials last refreshed its copy on 6 Nov 2026.