Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation

This study has been completed.
Sponsor:
Information provided by:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00153140
First received: September 7, 2005
Last updated: February 6, 2013
Last verified: February 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00153140     History of Changes
Other Study ID Numbers: 851-ZCC
Study First Received: September 7, 2005
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Tegaserod
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014