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ConstipationPhase 4NCT00164125

An Open Label Study of Chronic Polyethyleneglycol3350 Use in Constipated Patients

A Phase 4 study testing polyethyleneglycol3350 in people with Constipation, run by Braintree Laboratories at 47 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the safety of extended use of polyethyleneglycol3350 laxative in constipated patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Constipation
What is being tested?
polyethyleneglycol3350
How many people
300 participants
Where
47 sitesUnited States
Study dates
Jul 2003to Nov 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 years and older
  • All sexes
  • Adult, Older 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, 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. Patients with heme positive stool that can be attributed to hemorrhoids or anal fissures are eligible for inclusion.
  • Patients with hypo- or hyperthyroidism as determined by history, or screening TSH results.
  • Patients with known or suspected perforation or obstruction.
  • History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy.
  • Patients with a known history of organic cause for their constipation.
  • Patients meeting the ROME definition of Irritable Bowel Syndrome
Show all 24Show fewer
  • Patients currently taking 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 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

Trial locations and contacts

47 sites in 1 country.

47 sites in 1 country

United States47 sites

  • Study site

    Anaheim, California, 92801

  • Study site

    Atlanta, Georgia, 30328

  • Study site

    Austin, Texas, 78705

  • Study site

    Austin, Texas, 78745

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Cincinnati, Ohio, 45236

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Columbus, Ohio, 43212

  • Study site

    Dallas, Texas, 75231

  • Study site

    Fort Worth, Texas, 76135

  • Study site

    Glendale, Arizona, 85306

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Hoover, Alabama, 35216

  • Study site

    Kingsport, Tennessee, 37660

  • Study site

    Kissimmee, Florida, 34741

  • Study site

    Lake Worth, Florida, 33461

  • Study site

    Largo, Florida, 33770

  • Study site

    Laurel, Maryland, 20707

  • Study site

    Marietta, Georgia, 30067

  • Study site

    Memphis, Tennessee, 38120

  • Study site

    Mobile, Alabama, 36693

  • Study site

    Newport News, Virginia, 23606

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    Oakbrook Terrace, Illinois, 60181

  • Study site

    Ocoee, Florida, 34761

  • Study site

    Overland Park, Kansas, 66215

  • Study site

    Pell City, Alabama, 35128

  • Study site

    Peoria, Illinois, 61602

  • Study site

    Phoenix, Arizona, 85013

  • 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

    Scottsdale, Arizona, 85251

  • Study site

    South Bound Brook, New Jersey, 08880

  • Study site

    Springfield, Massachusetts, 01107

  • Study site

    St Louis, Missouri, 63017

  • Study site

    St. Petersburg, Florida, 33702

  • Study site

    St. Petersburg, Florida, 33707

  • Study site

    Tallassee, Alabama, 36078

  • Study site

    Tucson, Arizona, 85712

  • Study site

    Virginia Beach, Virginia, 23454

  • Study site

    Washington D.C., District of Columbia, 20037

  • Study site

    West Palm Beach, Florida, 33407

  • Study site

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

To evaluate the safety of extended use of polyethyleneglycol3350 laxative in constipated patients.

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.

  1. Safety (Adverse events and laboratory testing)

Secondary outcomes (1)

  1. Assessment of constipation using ROME I criteria and analysis of individual ROME I criteria

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2005 (estimated)
  2. Study startJul 2003
  3. Primary completionNov 2004

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00164125
Sponsor's protocol ID
851-CR3
Status last verified
Feb 2013
First submitted
9 Sep 2005
Last updated
7 Feb 2013
Results posted
No

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 47 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 24 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 47 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?

Safety (Adverse events and laboratory testing). 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 NCT00164125.

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.

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