Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation
NCT ID: NCT00153140
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
239 participants
INTERVENTIONAL
2004-07-31
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
NONE
Interventions
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polyethyleneglycol3350
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* 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.
18 Years
64 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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Mobile, Alabama, United States
Glendale, Arizona, United States
Anaheim, California, United States
Sacramento, California, United States
San Diego, California, United States
Lake Worth, Florida, United States
Largo, Florida, United States
St. Petersburg, Florida, United States
Laurel, Maryland, United States
Brighton, Massachusetts, United States
St Louis, Missouri, United States
Raleigh, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Greer, South Carolina, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Dallas, 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
Countries
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References
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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.
Other Identifiers
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851-ZCC
Identifier Type: -
Identifier Source: org_study_id
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