An Open Label Study of Chronic Polyethyleneglycol3350 Use in Constipated Patients

Completed · Phase 4

Conditions studied: Constipation

In brief

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

Key facts

Study ID

NCT00164125

Run by

Braintree Laboratories

People needed

300

Starts

2003-07-01

Last updated by the study team

2013-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Hoover, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Pell City, Alabama, United States
• Study site — Tallassee, Alabama, United States
• Study site — Glendale, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Sacramento, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Kissimmee, Florida, United States
• Study site — Lake Worth, Florida, United States
• Study site — Largo, Florida, United States
• Study site — Ocoee, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Oakbrook Terrace, Illinois, United States
• Study site — Peoria, Illinois, United States
• Study site — Overland Park, Kansas, United States
• Study site — Laurel, Maryland, United States
• Study site — Springfield, Massachusetts, United States

Full record on ClinicalTrials.gov

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