Clinical trial NCT00153140: Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation
Official title: Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria
Secondary outcomes:
measure: Analysis of individual ROME I criteria
measure: Safety (adverse event review)
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Glendale
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Lake Worth
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Laurel
country: United States
state: Maryland
city: Brighton
country: United States
state: Massachusetts
city: St. Louis
country: United States
state: Missouri
city: Raleigh
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Greer
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: San Angelo
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Newport News
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: University of South Alabama
name: Jorge Herrera, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Di Palma JA, Cleveland MV, McGowan J, Herrera JL. A randomized, multicenter comparison of polyethylene glycol laxative and tegaserod in treatment of patients with chronic constipation. Am J Gastroenterol. 2007 Sep;102(9):1964-71. doi: 10.1111/j.1572-0241.2007.01365.x. Epub 2007 Jun 15.