Status:
COMPLETED
Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation
Lead Sponsor:
Braintree Laboratories
Conditions:
Constipation
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT00153140
Start Date
July 1 2004
Last Update
February 7 2013
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
Mobile, Alabama, United States, 36693
2
Glendale, Arizona, United States, 85306
3
Anaheim, California, United States, 92801
4
Sacramento, California, United States, 95825