ConstipationPhase 4NCT00153140
Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation
A Phase 4 study testing polyethyleneglycol3350 in people with Constipation, run by Braintree Laboratories at 25 sites in United States.
Trial summary
The purpose of this study is to compare the safety and efficacy of extended polyethyleneglycol3350 use to tegaserod in patients with chronic constipation. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Constipation
- What is being tested?
- polyethyleneglycol3350
- How many people
- 239 participants
- Where
- 25 sitesUnited States
- Study dates
- Jul 2004to Oct 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 18 to 64 years
- All sexes
- Adult
Who may be able to join
- Male or female outpatients at least 18 years of age
- Constipated according to ROME I criteria
- If female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, double- barrier method, 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
- Are otherwise in good health, as judged by a physical examination
- In the investigator's judgment, patient is mentally competent to sign an instrument of informed consent
Who cannot join
- Patients with heme positive stool at screening that is not associated with hemorrhoids or anal fissures.
- Patients with hypo- or hyperthyroidism as determined by medical history.
- Patients with severe renal impairment.
- Patients with moderate or severe hepatic impairment.
- Patients with known or suspected perforation or obstruction.
- History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy.
Show all 28Show fewer
- Patients with symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions.
- Patients with a known history of organic cause for their constipation.
- Patients currently taking, or planning to take any of the following medications that are known to effect bowel habits:
- Antidiarrheals
- Antacids containing magnesium or aluminum salts
- Anticholinergics
- Antispasmodic agents
- Erythromycin and other macrolides
- Octreotide
- Lotronex, Zofran, or other 5-HT3 antagonists
- Zelnorm, or other 5-HT4 agonists
- Opiods/narcotic analgesics
- Prokinetics
- Serotonin re-uptake inhibitors or tricyclic antidepressants
- Calcium antagonists
- 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 allergy to tegaserod (or any of its excipients) or polyethyleneglycol.
- 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 who, within the past 30 days have participated in an investigational clinical study.
- Patients that have undergone a colonoscopy within 30 days of screening
- Patients that are currently taking, or have previously been treated with polyethyleneglycol3350 or tegaserod.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Study site
Anaheim, California, 92801
Study site
Austin, Texas, 78705
Study site
Brighton, Massachusetts, 02135
Study site
Cincinnati, Ohio, 45236
Study site
Dallas, Texas, 75234
Study site
Fort Worth, Texas, 76135
Study site
Glendale, Arizona, 85306
Study site
Greer, South Carolina, 29651
Study site
Lake Worth, Florida, 33461
Study site
Largo, Florida, 33770
Study site
Laurel, Maryland, 20707
Study site
Memphis, Tennessee, 38120
Study site
Mobile, Alabama, 36693
Study site
Newport News, Virginia, 23606
Study site
Norfolk, Virginia, 23502
Study site
Raleigh, North Carolina, 27609
Study site
Raleigh, North Carolina, 27612
Study site
Richmond, Virginia, 23294
Study site
Sacramento, California, 95825
Study site
Salt Lake City, Utah, 84121
Study site
San Angelo, Texas, 76904
Study site
San Diego, California, 92103
Study site
St Louis, Missouri, 63017
Study site
St. Petersburg, Florida, 33707
Study site
Winston-Salem, North Carolina, 27103
About this study
The purpose of this study is to compare the safety and efficacy of extended polyethyleneglycol3350 use to tegaserod in patients with chronic 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.
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 review)
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 startJul 2004
- Primary completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 239 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
- NCT00153140
- Sponsor's protocol ID
- 851-ZCC
- Status last verified
- Feb 2013
- First submitted
- 7 Sep 2005
- Last updated
- 7 Feb 2013
- Results posted
- No
Publications
Di Palma JA, Cleveland MV, McGowan J, Herrera JL. A randomized, multicenter comparison of polyethylene glycol laxative and tegaserod in treatment of patients with chronic constipation. Am J Gastroenterol. 2007 Sep;102(9):1964-71. doi: 10.1111/j.1572-0241.2007.01365.x. Epub 2007 Jun 15.
PubMed 17573794
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 vs Tegaserod in Treatment of Patients With Chronic Constipation
- ClinicalTrials.gov ID
- NCT00153140
- Acronym / sponsor ID
- 851-ZCC
- Conditions
- Constipation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Oct 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 compare the safety and efficacy of extended polyethyleneglycol3350 use to tegaserod in patients with chronic constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female outpatients at least 18 years of age
- Constipated according to ROME I criteria
- If female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, double- barrier method, 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
- Are otherwise in good health, as judged by a physical examination
- In the investigator's judgment, patient is mentally competent to sign an instrument of informed consent
Key exclusion criteria (28 listed)
- Patients with heme positive stool at screening that is not associated with hemorrhoids or anal fissures.
- Patients with hypo- or hyperthyroidism as determined by medical history.
- Patients with severe renal impairment.
- Patients with moderate or severe hepatic impairment.
- Patients with known or suspected perforation or obstruction.
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 review)
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.
- Derived from this study: PubMed 17573794Di Palma JA, Cleveland MV, McGowan J, Herrera JL. A randomized, multicenter comparison of polyethylene glycol laxative and tegaserod in treatment of patients with chronic constipation. Am J Gastroenterol. 2007 Sep;102(9):1964-71. doi: 10.1111/j.1572-0241.2007.01365.x. Epub 2007 Jun 15.
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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
25 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 25 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 5 inclusion and 28 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 25 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?
On the ClinicalTrials.gov record for NCT00153140, which also lists 1 linked publication.
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.