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Status:

COMPLETED

Extended Use of Polyethyleneglycol3350 Laxative in Constipated Patients

Lead Sponsor:

Braintree Laboratories

Conditions:

Constipation

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 1 2003

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT00153153

Start Date

August 1 2003

Last Update

February 7 2013

Active Locations (45)

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Page 1 of 12 (45 locations)

1

Hoover, Alabama, United States, 35216

2

Mobile, Alabama, United States, 36693

3

Pell City, Alabama, United States, 35128

4

Glendale, Arizona, United States, 85306