Overview
Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to compare the safety and efficacy of extended polyethyleneglycol3350 use to tegaserod in patients with chronic constipation.Phase:
Phase 4Details
Lead Sponsor:
Braintree LaboratoriesTreatments:
Polyethylene glycol 3350
Tegaserod
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.