Official Title: “Polyethyleneglycol3350 Vs Tegaserod in Treatment of Patients With Chronic Constipation”

The purpose of this study is to compare the safety and efficacy of extended polyethyleneglycol3350 use to tegaserod in patients with chronic constipation.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Intervention(s) in this Clinical Trial

• Drug: polyethyleneglycol3350

Primary Measures

• A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria

Secondary Measures

• Analysis of individual ROME I criteria
• Safety (adverse event review)

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Lead Sponsor: Braintree Laboratories

Overall Clinical Trial Officials and Contacts

Jorge Herrera, MD Principal Investigator University of South Alabama  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00153140

Study ID Number: 851-ZCC

ClinicalTrials.gov Identifier: NCT00153140

Health Authority: United States: Food and Drug Administration