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

September 9, 2005
February 6, 2013
July 2003
November 2004   (final data collection date for primary outcome measure)
Safety (Adverse events and laboratory testing)
Same as current
Complete list of historical versions of study NCT00164125 on ClinicalTrials.gov Archive Site
Assessment of constipation using ROME I criteria and analysis of individual ROME I criteria
Same as current
Not Provided
Not Provided
 
An Open Label Study of Chronic Polyethyleneglycol3350 Use in Constipated Patients
An Open Label Study of Chronic Polyethyleneglycol3350 Use in Constipated Patients

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

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Constipation
Drug: polyethyleneglycol3350
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
Not Provided
November 2004   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00164125
851-CR3
Not Provided
Not Provided
Braintree Laboratories
Not Provided
Principal Investigator: Jorge Herrera, MD University of South Alabama
Braintree Laboratories
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP