Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation

This study has been completed.
Sponsor:
Information provided by:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00153140
First received: September 7, 2005
Last updated: February 6, 2013
Last verified: February 2013

September 7, 2005
February 6, 2013
July 2004
October 2004   (final data collection date for primary outcome measure)
A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria
Same as current
Complete list of historical versions of study NCT00153140 on ClinicalTrials.gov Archive Site
  • Analysis of individual ROME I criteria
  • Safety (adverse event review)
Same as current
Not Provided
Not Provided
 
Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Constipation
Drug: polyethyleneglycol3350
Not Provided
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. Epub 2007 Jun 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
239
Not Provided
October 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years to 64 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00153140
851-ZCC
Not Provided
Not Provided
Braintree Laboratories
Not Provided
Principal Investigator: Jorge Herrera, MD University of South Alabama
Braintree Laboratories
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP