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Polyethyleneglycol3350 Vs Tegaserod in Treatment of Patients With Chronic Constipation
This study has been completed.
First Received: September 7, 2005   No Changes Posted
Sponsored by: Braintree Laboratories
Information provided by: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT00153140
  Purpose

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

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title: Polyethyleneglycol3350 Vs Tegaserod in Treatment of Patients With Chronic Constipation

Resource links provided by NLM:


Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:
  • A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria

Secondary Outcome Measures:
  • Analysis of individual ROME I criteria
  • Safety (adverse event review)

Estimated Enrollment: 239
Study Start Date: July 2004
  Eligibility

Ages Eligible for Study:   18 Years to 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00153140

  Show 25 Study Locations
Sponsors and Collaborators
Braintree Laboratories
Investigators
Principal Investigator: Jorge Herrera, MD University of South Alabama
  More Information

No publications provided by Braintree Laboratories

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: 851-ZCC
Study First Received: September 7, 2005
Last Updated: September 7, 2005
ClinicalTrials.gov Identifier: NCT00153140     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Signs and Symptoms
Signs and Symptoms, Digestive
Constipation
Tegaserod

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive
Constipation

ClinicalTrials.gov processed this record on August 30, 2009