The purpose of this study is to compare the safety and efficacy of extended polyethyleneglycol3350 use to tegaserod in patients with chronic constipation.

Condition	Intervention	Phase
Constipation	Drug: polyethyleneglycol3350	Phase IV

Further Study Details: 

Primary Outcomes: A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria
Secondary Outcomes: Analysis of individual ROME I criteria; Safety (adverse event review)
Expected Total Enrollment:  239

Ages Eligible for Study:  18 Years   -   64 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 • 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.

Alabama
      Mobile,  Alabama,  36693,  United States
Arizona
      Glendale,  Arizona,  85306,  United States
California
      San Diego,  California,  92103,  United States
      Sacramento,  California,  95825,  United States
      Anaheim,  California,  92801,  United States
Florida
      Lake Worth,  Florida,  33461,  United States
      St. Petersburg,  Florida,  33707,  United States
      Largo,  Florida,  33770,  United States
Maryland
      Laurel,  Maryland,  20707,  United States
Massachusetts
      Brighton,  Massachusetts,  02135,  United States
Missouri
      St. Louis,  Missouri,  63017,  United States
North Carolina
      Raleigh,  North Carolina,  27612,  United States
      Winston Salem,  North Carolina,  27103,  United States
      Raleigh,  North Carolina,  27609,  United States
Ohio
      Cincinnati,  Ohio,  45236,  United States
South Carolina
      Greer,  South Carolina,  29651,  United States
Tennessee
      Memphis,  Tennessee,  38120,  United States
Texas
      Austin,  Texas,  78705,  United States
      San Angelo,  Texas,  76904,  United States
      Fort Worth,  Texas,  76135,  United States
      Dallas,  Texas,  75234,  United States
Utah
      Salt Lake City,  Utah,  84121,  United States
Virginia
      Newport News,  Virginia,  23606,  United States
      Richmond,  Virginia,  23294,  United States
      Norfolk,  Virginia,  23502,  United States

Study chairs or principal investigators

Jorge Herrera, MD,  Principal Investigator,  University of South Alabama   

Study ID Numbers:  851-ZCC
Last Updated:  September 9, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00153140
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13