An Open Label Study of Chronic Polyethyleneglycol3350 Use in Constipated Patients

This study has been completed.
Sponsor:
Information provided by:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00164125
First received: September 9, 2005
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

To evaluate the safety of extended use of polyethyleneglycol3350 laxative in constipated patients.


Condition Intervention Phase
Constipation
Drug: polyethyleneglycol3350
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study of Chronic Polyethyleneglycol3350 Use in Constipated Patients

Resource links provided by NLM:


Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:
  • Safety (Adverse events and laboratory testing)

Secondary Outcome Measures:
  • Assessment of constipation using ROME I criteria and analysis of individual ROME I criteria

Estimated Enrollment: 300
Study Start Date: July 2003
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
  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: NCT00164125

  Hide Study Locations
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
United States, Arizona
Glendale, Arizona, United States, 85306
Phoenix, Arizona, United States, 85013
Scottsdale, Arizona, United States, 85251
Tucson, Arizona, United States, 85712
United States, California
Anaheim, California, United States, 92801
Sacramento, California, United States, 95825
United States, District of Columbia
Washington, District of Columbia, United States, 20037
United States, 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, 33702
St. Petersburg, Florida, United States, 33707
West Palm Beach, Florida, United States, 33407
United States, Georgia
Atlanta, Georgia, United States, 30328
Marietta, Georgia, United States, 30067
United States, Illinois
Oakbrook Terrace, Illinois, United States, 60181
Peoria, Illinois, United States, 61602
United States, Kansas
Overland Park, Kansas, United States, 66215
United States, Maryland
Laurel, Maryland, United States, 20707
United States, Massachusetts
Springfield, Massachusetts, United States, 01107
United States, Missouri
St. Louis, Missouri, United States, 63017
United States, New Jersey
South Bound Brook, New Jersey, United States, 08880
United States, North Carolina
Raleigh, North Carolina, United States, 27612
Raleigh, North Carolina, United States, 27609
Wilmington, North Carolina, United States, 28401
United States, Ohio
Cincinnati, Ohio, United States, 45236
Cincinnati, Ohio, United States, 45242
Columbus, Ohio, United States, 43212
United States, South Carolina
Greer, South Carolina, United States, 29651
United States, Tennessee
Bristol, Tennessee, United States, 37620
Kingsport, Tennessee, United States, 37660
Memphis, Tennessee, United States, 38120
United States, 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
United States, Utah
Salt Lake City, Utah, United States, 84121
United States, Virginia
Newport News, Virginia, United States, 23606
Norfolk, Virginia, United States, 23502
Richmond, Virginia, United States, 23294
Virginia Beach, Virginia, United States, 23454
Sponsors and Collaborators
Braintree Laboratories
Investigators
Principal Investigator: Jorge Herrera, MD University of South Alabama
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00164125     History of Changes
Other Study ID Numbers: 851-CR3
Study First Received: September 9, 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

ClinicalTrials.gov processed this record on August 19, 2014