An Open Label Study of Chronic Polyethyleneglycol3350 Use in Constipated Patients

February 6, 2013 updated by: Braintree Laboratories
To evaluate the safety of extended use of polyethyleneglycol3350 laxative in constipated patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

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
      • Hoover, Alabama, United States, 35216
      • Mobile, Alabama, United States, 36693
      • Pell City, Alabama, United States, 35128
      • Tallassee, Alabama, United States, 36078
    • Arizona
      • Glendale, Arizona, United States, 85306
      • Phoenix, Arizona, United States, 85013
      • Scottsdale, Arizona, United States, 85251
      • Tucson, Arizona, United States, 85712
    • California
      • Anaheim, California, United States, 92801
      • Sacramento, California, United States, 95825
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
    • Florida
      • Kissimmee, Florida, United States, 34741
      • Lake Worth, Florida, United States, 33461
      • Largo, Florida, United States, 33770
      • Ocoee, Florida, United States, 34761
      • St. Petersburg, Florida, United States, 33707
      • St. Petersburg, Florida, United States, 33702
      • West Palm Beach, Florida, United States, 33407
    • Georgia
      • Atlanta, Georgia, United States, 30328
      • Marietta, Georgia, United States, 30067
    • Illinois
      • Oakbrook Terrace, Illinois, United States, 60181
      • Peoria, Illinois, United States, 61602
    • Kansas
      • Overland Park, Kansas, United States, 66215
    • Maryland
      • Laurel, Maryland, United States, 20707
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
    • Missouri
      • St. Louis, Missouri, United States, 63017
    • New Jersey
      • South Bound Brook, New Jersey, United States, 08880
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
      • Raleigh, North Carolina, United States, 27612
      • Wilmington, North Carolina, United States, 28401
    • Ohio
      • Cincinnati, Ohio, United States, 45242
      • Cincinnati, Ohio, United States, 45236
      • Columbus, Ohio, United States, 43212
    • South Carolina
      • Greer, South Carolina, United States, 29651
    • Tennessee
      • Bristol, Tennessee, United States, 37620
      • Kingsport, Tennessee, United States, 37660
      • Memphis, Tennessee, United States, 38120
    • Texas
      • Austin, Texas, United States, 78705
      • Austin, Texas, United States, 78745
      • Dallas, Texas, United States, 75231
      • 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
      • Virginia Beach, Virginia, United States, 23454

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion 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, 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. Patients with heme positive stool that can be attributed to hemorrhoids or anal fissures are eligible for inclusion.
  • Patients with hypo- or hyperthyroidism as determined by history, or screening TSH results.
  • Patients with known or suspected perforation or obstruction.
  • History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy.
  • Patients with a known history of organic cause for their constipation.
  • Patients meeting the ROME definition of Irritable Bowel Syndrome

  • Patients currently taking 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 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

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety (Adverse events and laboratory testing)

Secondary Outcome Measures

Outcome Measure
Assessment of constipation using ROME I criteria and analysis of individual ROME I criteria

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

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, 2003

Primary Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 14, 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-CR3

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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