Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and efficacy of extended polyethyleneglycol3350 use to tegaserod in patients with chronic constipation.

Official Title
-----------------
Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Drug: polyethyleneglycol3350


Participation Criteria
=================
Eligibility 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, double- barrier method, 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 that is not associated with hemorrhoids or anal fissures. Patients with hypo- or hyperthyroidism as determined by medical history. Patients with severe renal impairment. Patients with moderate or severe hepatic impairment. Patients with known or suspected perforation or obstruction. History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy. Patients with symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions. Patients with a known history of organic cause for their constipation. Patients currently taking, or planning to take 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 tegaserod (or any of its excipients) or 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. Patients that have undergone a colonoscopy within 30 days of screening Patients that are currently taking, or have previously been treated with polyethyleneglycol3350 or tegaserod.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of individual ROME I criteria |  |  | 
| Safety (adverse event review) |  |  |