Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation

February 6, 2013 updated by: Braintree Laboratories
The purpose of this study is to compare the safety and efficacy of extended polyethyleneglycol3350 use to tegaserod in patients with chronic constipation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

239

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria

Secondary Outcome Measures

Outcome Measure
Analysis of individual ROME I criteria
Safety (adverse event review)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Braintree Laboratories

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

February 7, 2013

Last Update Submitted That Met QC Criteria

February 6, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 851-ZCC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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