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Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation

Sponsor
Braintree Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT00153140
Collaborator
(none)
239
Enrollment
25
Locations
9.6
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation
Study Start Date :
Jul 1, 2004
Actual Primary Completion Date :
Oct 1, 2004

Outcome Measures

Primary Outcome Measures

  1. A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria []

Secondary Outcome Measures

  1. Analysis of individual ROME I criteria []

  2. Safety (adverse event review) []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mobile Alabama United States 36693
2 Glendale Arizona United States 85306
3 Anaheim California United States 92801
4 Sacramento California United States 95825
5 San Diego California United States 92103
6 Lake Worth Florida United States 33461
7 Largo Florida United States 33770
8 St. Petersburg Florida United States 33707
9 Laurel Maryland United States 20707
10 Brighton Massachusetts United States 02135
11 St. Louis Missouri United States 63017
12 Raleigh North Carolina United States 27609
13 Raleigh North Carolina United States 27612
14 Winston-Salem North Carolina United States 27103
15 Cincinnati Ohio United States 45236
16 Greer South Carolina United States 29651
17 Memphis Tennessee United States 38120
18 Austin Texas United States 78705
19 Dallas Texas United States 75234
20 Fort Worth Texas United States 76135
21 San Angelo Texas United States 76904
22 Salt Lake City Utah United States 84121
23 Newport News Virginia United States 23606
24 Norfolk Virginia United States 23502
25 Richmond Virginia United States 23294

Sponsors and Collaborators

  • Braintree Laboratories

Investigators

  • Principal Investigator: Jorge Herrera, MD, University of South Alabama

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00153140
Other Study ID Numbers:
  • 851-ZCC
First Posted:
Sep 12, 2005
Last Update Posted:
Feb 7, 2013
Last Verified:
Feb 1, 2013
Additional relevant MeSH terms:
Constipation
Polyethylene glycol 3350

Study Results

No Results Posted as of Feb 7, 2013