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Extended Use of Polyethyleneglycol3350 Laxative in Constipated Patients

Primary Purpose

Constipation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
polyethyleneglycol3350
Sponsored by
Braintree Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria: Male or female outpatients at least 18 years of age Constipated according to ROME I criteria On average, fewer than 3 satisfactory BMs per week during the observation period If female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, 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. Patients with heme positive stool that can be attributed to hemorrhoids or anal fissures are eligible for inclusion. Patients with hypo- or hyperthyroidism as determined by history, or screening TSH results. Patients with known or suspected perforation or obstruction. History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy. Patients with a known history of organic cause for their constipation. Patients meeting the ROME definition of Irritable Bowel Syndrome Patients currently taking 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 corn or polyethylene glycol. 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 beginning the 14 day observation period. Patients that are currently taking, or have previously been treated with polyethyleneglycol3350

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Analysis of individual ROME I criteria
Safety (adverse events and laboratory testing)

Full Information

First Posted
September 7, 2005
Last Updated
February 6, 2013
Sponsor
Braintree Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00153153
Brief Title
Extended Use of Polyethyleneglycol3350 Laxative in Constipated Patients
Official Title
Extended Use of Polyethyleneglycol3350 Laxative in Constipated Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Braintree Laboratories

4. Oversight

5. Study Description

Brief Summary
To evaluate the safety and efficacy of extended use of polyethyleneglycol3350 laxative as compared to placebo in constipated patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
polyethyleneglycol3350
Primary Outcome Measure Information:
Title
A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria
Secondary Outcome Measure Information:
Title
Analysis of individual ROME I criteria
Title
Safety (adverse events and laboratory testing)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: Male or female outpatients at least 18 years of age Constipated according to ROME I criteria On average, fewer than 3 satisfactory BMs per week during the observation period If female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, 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. Patients with heme positive stool that can be attributed to hemorrhoids or anal fissures are eligible for inclusion. Patients with hypo- or hyperthyroidism as determined by history, or screening TSH results. Patients with known or suspected perforation or obstruction. History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy. Patients with a known history of organic cause for their constipation. Patients meeting the ROME definition of Irritable Bowel Syndrome Patients currently taking 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 corn or polyethylene glycol. 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 beginning the 14 day observation period. Patients that are currently taking, or have previously been treated with polyethyleneglycol3350
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Herrera, MD
Organizational Affiliation
University of South Alabama
Official's Role
Principal Investigator
Facility Information:
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36693
Country
United States
City
Pell City
State/Province
Alabama
ZIP/Postal Code
35128
Country
United States
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33702
Country
United States
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30067
Country
United States
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
City
Laurel
State/Province
Maryland
ZIP/Postal Code
20707
Country
United States
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
City
South Bound Brook
State/Province
New Jersey
ZIP/Postal Code
08880
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36120087
Citation
Menees SB, Lembo AJ, Chey WD. Polyethylene Glycol 3350 in the Treatment of Chronic Idiopathic Constipation: Post hoc Analysis Using FDA Endpoints. Can J Gastroenterol Hepatol. 2022 Sep 9;2022:3533504. doi: 10.1155/2022/3533504. eCollection 2022.
Results Reference
derived

Learn more about this trial

Extended Use of Polyethyleneglycol3350 Laxative in Constipated Patients

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