Extended Use of Polyethyleneglycol3350 Laxative in Constipated Patients
NCT ID: NCT00153153
Last Updated: 2013-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
300 participants
INTERVENTIONAL
2003-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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polyethyleneglycol3350
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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 corn or polyethylene glycol.
* 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 beginning the 14 day observation period.
* Patients that are currently taking, or have previously been treated with polyethyleneglycol3350
18 Years
ALL
No
Sponsors
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Braintree Laboratories
INDUSTRY
Principal Investigators
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Jorge Herrera, MD
Role: PRINCIPAL_INVESTIGATOR
University of South Alabama
Locations
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Hoover, Alabama, United States
Mobile, Alabama, United States
Pell City, Alabama, United States
Glendale, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Sacramento, California, United States
Washington D.C., District of Columbia, United States
Kissimmee, Florida, United States
Lake Worth, Florida, United States
Largo, Florida, United States
Ocoee, Florida, United States
St. Petersburg, Florida, United States
St. Petersburg, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Oakbrook Terrace, Illinois, United States
Peoria, Illinois, United States
Overland Park, Kansas, United States
Laurel, Maryland, United States
Springfield, Massachusetts, United States
St Louis, Missouri, United States
South Bound Brook, New Jersey, United States
Raleigh, North Carolina, United States
Raleigh, North Carolina, United States
Wilmington, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Greer, South Carolina, United States
Bristol, Tennessee, United States
Kingsport, Tennessee, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Austin, Texas, United States
Fort Worth, Texas, United States
San Angelo, Texas, United States
Salt Lake City, Utah, United States
Newport News, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Virginia Beach, Virginia, United States
Countries
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References
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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.
Other Identifiers
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851-CR1
Identifier Type: -
Identifier Source: org_study_id
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