NCT Number: NCT00153140
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.
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Conditions
Age range
18 year–64 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Mobile, Alabama, United States
Who can participate
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria
Secondary outcomes
-
Analysis of individual ROME I criteria
-
Safety (adverse event review)
Sponsors and collaborators
Lead sponsor
Braintree Laboratories
Industry
Registry information
Important dates
- Study start
- 2004
- Primary completion
- 2004
- First posted
- Sep 12, 2005
- Registry last updated
- Feb 7, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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