NCT00153140CompletedPhase 4
Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation
Braintree Laboratories25 sites in 1 country239 target enrollmentStarted: July 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 239
- Locations
- 25
- Primary Endpoint
- A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
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)
Investigators
Study Sites (25)
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