Extended Use of Polyethyleneglycol3350 Laxative in Constipated Patients

This study has been completed.
Sponsor:
Information provided by:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00153153
First received: September 7, 2005
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

To evaluate the safety and efficacy of extended use of polyethyleneglycol3350 laxative as compared to placebo in constipated patients.


Condition Intervention Phase
Constipation
Drug: polyethyleneglycol3350
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Extended Use of Polyethyleneglycol3350 Laxative in Constipated Patients

Resource links provided by NLM:


Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:
  • A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria

Secondary Outcome Measures:
  • Analysis of individual ROME I criteria
  • Safety (adverse events and laboratory testing)

Estimated Enrollment: 300
Study Start Date: August 2003
Primary Completion Date: December 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:

  • Male or female outpatients at least 18 years of age
  • Constipated according to ROME I criteria
  • On average, fewer than 3 satisfactory BMs per week during the observation period
  • 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 corn or polyethylene glycol.
  • 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 beginning the 14 day observation period.
  • Patients that are currently taking, or have previously been treated with polyethyleneglycol3350
  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: NCT00153153

  Show 45 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: NCT00153153     History of Changes
Other Study ID Numbers: 851-CR1
Study First Received: September 7, 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
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014