An Open Label Study of Chronic Polyethyleneglycol3350 Use in Constipated Patients
Constipation
About this trial
This is an interventional treatment trial for Constipation
Eligibility 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