An Open Label Study of Chronic Polyethyleneglycol3350 Use in Constipated Patients

Study Overview
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Brief Summary
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To evaluate the safety of extended use of polyethyleneglycol3350 laxative in constipated patients.

Official Title
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An Open Label Study of Chronic Polyethyleneglycol3350 Use in Constipated Patients

Conditions
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Constipation

Intervention / Treatment
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* Drug: polyethyleneglycol3350


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: polyethyleneglycol3350|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Adverse events and laboratory testing) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of constipation using ROME I criteria and analysis of individual ROME I criteria |  |  |