Clinical trial NCT00153153: Extended Use of Polyethyleneglycol3350 Laxative in Constipated Patients
Official title: Extended Use of Polyethyleneglycol3350 Laxative in Constipated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

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 events and laboratory testing)
Other outcomes:
Locations:
city: Hoover
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Pell City
country: United States
state: Alabama
city: Glendale
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Kissimmee
country: United States
state: Florida
city: Lake Worth
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Ocoee
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Oakbrook Terrace
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: Overland Park
country: United States
state: Kansas
city: Laurel
country: United States
state: Maryland
city: Springfield
country: United States
state: Massachusetts
city: St. Louis
country: United States
state: Missouri
city: South Bound Brook
country: United States
state: New Jersey
city: Raleigh
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Greer
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Austin
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
city: Virginia Beach
country: United States
state: Virginia
Study officials:
affiliation: University of South Alabama
name: Jorge Herrera, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.