An Open Label Study of Chronic Polyethyleneglycol3350 Use in Constipated Patients
1 other identifier
interventional
300
1 country
47
Brief Summary
To evaluate the safety of extended use of polyethyleneglycol3350 laxative in constipated patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedFebruary 7, 2013
February 1, 2013
1.3 years
September 9, 2005
February 6, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Safety (Adverse events and laboratory testing)
Secondary Outcomes (1)
Assessment of constipation using ROME I criteria and analysis of individual ROME I criteria
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Unknown Facility
Hoover, Alabama, 35216, United States
Unknown Facility
Mobile, Alabama, 36693, United States
Unknown Facility
Pell City, Alabama, 35128, United States
Unknown Facility
Tallassee, Alabama, 36078, United States
Unknown Facility
Glendale, Arizona, 85306, United States
Unknown Facility
Phoenix, Arizona, 85013, United States
Unknown Facility
Scottsdale, Arizona, 85251, United States
Unknown Facility
Tucson, Arizona, 85712, United States
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
Sacramento, California, 95825, United States
Unknown Facility
Washington D.C., District of Columbia, 20037, United States
Unknown Facility
Kissimmee, Florida, 34741, United States
Unknown Facility
Lake Worth, Florida, 33461, United States
Unknown Facility
Largo, Florida, 33770, United States
Unknown Facility
Ocoee, Florida, 34761, United States
Unknown Facility
St. Petersburg, Florida, 33702, United States
Unknown Facility
St. Petersburg, Florida, 33707, United States
Unknown Facility
West Palm Beach, Florida, 33407, United States
Unknown Facility
Atlanta, Georgia, 30328, United States
Unknown Facility
Marietta, Georgia, 30067, United States
Unknown Facility
Oakbrook Terrace, Illinois, 60181, United States
Unknown Facility
Peoria, Illinois, 61602, United States
Unknown Facility
Overland Park, Kansas, 66215, United States
Unknown Facility
Laurel, Maryland, 20707, United States
Unknown Facility
Springfield, Massachusetts, 01107, United States
Unknown Facility
St Louis, Missouri, 63017, United States
Unknown Facility
South Bound Brook, New Jersey, 08880, United States
Unknown Facility
Raleigh, North Carolina, 27609, United States
Unknown Facility
Raleigh, North Carolina, 27612, United States
Unknown Facility
Wilmington, North Carolina, 28401, United States
Unknown Facility
Cincinnati, Ohio, 45236, United States
Unknown Facility
Cincinnati, Ohio, 45242, United States
Unknown Facility
Columbus, Ohio, 43212, United States
Unknown Facility
Greer, South Carolina, 29651, United States
Unknown Facility
Bristol, Tennessee, 37620, United States
Unknown Facility
Kingsport, Tennessee, 37660, United States
Unknown Facility
Memphis, Tennessee, 38120, United States
Unknown Facility
Austin, Texas, 78705, United States
Unknown Facility
Austin, Texas, 78745, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Fort Worth, Texas, 76135, United States
Unknown Facility
San Angelo, Texas, 76904, United States
Unknown Facility
Salt Lake City, Utah, 84121, United States
Unknown Facility
Newport News, Virginia, 23606, United States
Unknown Facility
Norfolk, Virginia, 23502, United States
Unknown Facility
Richmond, Virginia, 23294, United States
Unknown Facility
Virginia Beach, Virginia, 23454, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jorge Herrera, MD
University of South Alabama
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 14, 2005
Study Start
July 1, 2003
Primary Completion
November 1, 2004
Last Updated
February 7, 2013
Record last verified: 2013-02