ConstipationPhase 4NCT00583609
A Pilot Study of a New PEG3350 Dose Formulation For Use in Constipated Children
A Phase 4 study testing PEG3350 in people with Constipation, run by Braintree Laboratories at 2 sites in United States.
Trial summary
To evaluate the patient acceptance of a new PEG3350 dose formulation in children currently treated with PEG3350 powder for treatment 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?
- PEG3350
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2007to Jul 2008
- 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
- No healthy volunteers
- Child
Who may be able to join
- Male or female constipated outpatients between the ages of 4 and 16
- Currently taking a dose of PEG 3350 powder up to a maximum of 17g per day that has been consistent for at least 4 weeks, or if less than 4 weeks, the investigator testifies that the patient is stable
- 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 for the duration of the study
- In the investigator's judgment, patient or guardian is mentally competent to sign an instrument of informed consent
Who cannot join
- Patients who are impacted at baseline exam
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Little Rock, Arkansas
Study site
Morristown, New Jersey
About this study
To evaluate the patient acceptance of a new PEG3350 dose formulation in children currently treated with PEG3350 powder for treatment of constipation.
- Conditions
- Constipation
- Being tested
- PEG3350
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG3350Drug
PEG3350
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PEG3350 Receives: Drug: PEG3350 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy will be measured by analysis of patient self reported bowel movement (BM) data
Measured: 2 weeks
Secondary outcomes (1)
Adverse events
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startSep 2007
- Primary completionJul 2008
- Study completionJul 2008
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John McGowan, Study director, Braintree Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583609
- Sponsor's protocol ID
- 851-PP-03
- Status last verified
- Sep 2009
- First submitted
- 20 Dec 2007
- Last updated
- 28 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a New PEG3350 Dose Formulation For Use in Constipated Children
- ClinicalTrials.gov ID
- NCT00583609
- Acronym / sponsor ID
- 851-PP-03
- Conditions
- Constipation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 31 Dec 2007 (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.
To evaluate the patient acceptance of a new PEG3350 dose formulation in children currently treated with PEG3350 powder for treatment of constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PEG3350PEG3350 |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female constipated outpatients between the ages of 4 and 16
- Currently taking a dose of PEG 3350 powder up to a maximum of 17g per day that has been consistent for at least 4 weeks, or if less than 4 weeks, the investigator testifies that the patient is stable
- 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 for the duration of the study
Key exclusion criteria (10 listed)
- Patients who are impacted at baseline exam
- 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)
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 |
|---|---|---|
| PEG3350PEG3350 | Drug | 1 |
Primary outcome
Efficacy will be measured by analysis of patient self reported bowel movement (BM) data
Time frame: 2 weeks
1 secondary outcome
Adverse events
Time frame: 2 weeks
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 28 Sep 2009.
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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.
John McGowan study director
Braintree Laboratories, Inc.
2 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 PEG3350 in people with Constipation, run by Braintree Laboratories at 2 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 6 inclusion and 10 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 28 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Efficacy will be measured by analysis of patient self reported bowel movement (BM) data (time frame: 2 weeks). 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 28 Sep 2009.