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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00164125

  Show 47 Study Locations
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 April 17, 2014