ConstipationPhase 4NCT00153127
Comparison of PolyethyleneGlycol and Placebo for Relief of Constipation From Constipating Medications
A Phase 4 study testing polyethyleneglycol3350 in people with Constipation, run by Braintree Laboratories at 4 sites in United States.
Trial summary
The purpose of this study is to assess treatment responses comparing a newly FDA-approved PEG laxative versus placebo. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- polyethyleneglycol3350
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2001to 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 19 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Adult male or female ambulatory outpatient age 19 or older.
- Patients meet ROME II Criteria
- Patients not meeting ROME IBS criteria
- Use of a constipating medication (>= 3% in PDR)
- If female and of childbearing potential, patient must be surgically sterilized or 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
- Written informed consent.
Who cannot join
- Known or suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease.
- Prior small bowel or colonic resection or colostomy.
- Weight < 80 lbs.
- Unwilling or unable to undergo any colon diagnostic examinations at the end of the study if not performed within 5 years of the informed consent date advised by clinically accepted indications.
- Positive stool hemoccult.
- Significant cardiac, renal or hepatic insufficiency.
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- Pregnant or expecting to become pregnant within 120 days of study enrollment.
- Lactating or breast feeding.
- Subjects who in the opinion of the investigator would be unable to comply adequately with the study plan.
- Use of investigational drugs in the last 30 days.
- Patients with known allergy to PEG or PEG medications such as PEG or sulfate-free electrolyte lavage solutions
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Mobile, Alabama, 36693
Study site
Raleigh, North Carolina, 27612
Study site
St Louis, Missouri, 63141
Study site
St. Petersburg, Florida, 33707
About this study
Official title: Comparison of Braintree PolyethyleneGlycol(PEG) Laxative and Placebo for Relief of Constipation From Constipating Medications
The purpose of this study is to assess treatment responses comparing a newly FDA-approved PEG laxative versus placebo.
- 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.
A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria
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 startNov 2001
- 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
- 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
- Jorge Herrera, MD, Principal investigator, University of South Alabama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153127
- Sponsor's protocol ID
- 851-17
- 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
- Comparison of Braintree PolyethyleneGlycol(PEG) Laxative and Placebo for Relief of Constipation From Constipating Medications
- ClinicalTrials.gov ID
- NCT00153127
- Acronym / sponsor ID
- 851-17
- Conditions
- Constipation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Nov 2001
- 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.
The purpose of this study is to assess treatment responses comparing a newly FDA-approved PEG laxative versus placebo.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult male or female ambulatory outpatient age 19 or older.
- Patients meet ROME II Criteria
- Patients not meeting ROME IBS criteria
- Use of a constipating medication (>= 3% in PDR)
- If female and of childbearing potential, patient must be surgically sterilized or 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
Key exclusion criteria (11 listed)
- Known or suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease.
- Prior small bowel or colonic resection or colostomy.
- Weight < 80 lbs.
- Unwilling or unable to undergo any colon diagnostic examinations at the end of the study if not performed within 5 years of the informed consent date advised by clinically accepted indications.
- Positive stool hemoccult.
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
A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria
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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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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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.
Jorge Herrera, MD principal investigator
University of South Alabama
4 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 4 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 11 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 4 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?
A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria. 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.