Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation

Completed · Phase 4

Conditions studied: Constipation

In brief

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

Key facts

Study ID

NCT00153140

Run by

Braintree Laboratories

People needed

239

Starts

2004-07-01

Last updated by the study team

2013-02-07

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Glendale, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Lake Worth, Florida, United States
• Study site — Largo, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Laurel, Maryland, United States
• Study site — Brighton, Massachusetts, United States
• Study site — St Louis, Missouri, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Greer, South Carolina, United States
• Study site — Memphis, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Fort Worth, Texas, United States
• Study site — San Angelo, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Newport News, Virginia, United States
• Study site — Norfolk, Virginia, United States
• Study site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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