Extended Use of Polyethyleneglycol3350 Laxative in Constipated Patients

Constipation Clinical Trial

Official title:

Extended Use of Polyethyleneglycol3350 Laxative in Constipated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153153
• Other study ID #: 851-CR1
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2005
• Last updated: February 6, 2013
• Start date: August 2003

Study information

• Verified date: February 2013
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. primary completion date: December 2004
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• polyethyleneglycol3350

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria
Secondary	Analysis of individual ROME I criteria
Secondary	Safety (adverse events and laboratory testing)