Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation
1 other identifier
interventional
239
1 country
25
Brief Summary
The purpose of this study is to compare the safety and efficacy of extended polyethyleneglycol3350 use to tegaserod in patients with chronic constipation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
25 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
July 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 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
3 months
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 event review)
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, 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
You may not qualify if:
- Patients with heme positive stool at screening that is not associated with hemorrhoids or anal fissures.
- 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
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Unknown Facility
Mobile, Alabama, 36693, United States
Unknown Facility
Glendale, Arizona, 85306, United States
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
Sacramento, California, 95825, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
Lake Worth, Florida, 33461, United States
Unknown Facility
Largo, Florida, 33770, United States
Unknown Facility
St. Petersburg, Florida, 33707, United States
Unknown Facility
Laurel, Maryland, 20707, United States
Unknown Facility
Brighton, Massachusetts, 02135, United States
Unknown Facility
St Louis, Missouri, 63017, United States
Unknown Facility
Raleigh, North Carolina, 27609, United States
Unknown Facility
Raleigh, North Carolina, 27612, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Cincinnati, Ohio, 45236, United States
Unknown Facility
Greer, South Carolina, 29651, United States
Unknown Facility
Memphis, Tennessee, 38120, United States
Unknown Facility
Austin, Texas, 78705, United States
Unknown Facility
Dallas, Texas, 75234, 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
Related Publications (1)
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.
PMID: 17573794DERIVED
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
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 12, 2005
Study Start
July 1, 2004
Primary Completion
October 1, 2004
Last Updated
February 7, 2013
Record last verified: 2013-02