Extended Use of Polyethyleneglycol3350 Laxative in Constipated Patients
1 other identifier
interventional
300
1 country
45
Brief Summary
To evaluate the safety and efficacy of extended use of polyethyleneglycol3350 laxative as compared to placebo 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
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedFebruary 7, 2013
February 1, 2013
1.3 years
September 7, 2005
February 6, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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 events and laboratory testing)
Interventions
Eligibility Criteria
You may qualify if:
- Male or female outpatients at least 18 years of age
- Constipated according to ROME I criteria
- On average, fewer than 3 satisfactory BMs per week during the observation period
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Unknown Facility
Hoover, Alabama, 35216, United States
Unknown Facility
Mobile, Alabama, 36693, United States
Unknown Facility
Pell City, Alabama, 35128, 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
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
Related Publications (1)
Menees SB, Lembo AJ, Chey WD. Polyethylene Glycol 3350 in the Treatment of Chronic Idiopathic Constipation: Post hoc Analysis Using FDA Endpoints. Can J Gastroenterol Hepatol. 2022 Sep 9;2022:3533504. doi: 10.1155/2022/3533504. eCollection 2022.
PMID: 36120087DERIVED
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
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 12, 2005
Study Start
August 1, 2003
Primary Completion
December 1, 2004
Last Updated
February 7, 2013
Record last verified: 2013-02