Comparison of PolyethyleneGlycol and Placebo for Relief of Constipation From Constipating Medications

Comparison of Braintree PolyethyleneGlycol(PEG) Laxative and Placebo for Relief of Constipation From Constipating Medications

The purpose of this study is to assess treatment responses comparing a newly FDA-approved PEG laxative versus placebo.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Drug: polyethyleneglycol3350

• Study Type: Interventional
• Enrollment: 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36693
  • Florida
    • St. Petersburg, Florida, United States, 33707
  • Missouri
    • St. Louis, Missouri, United States, 63141
  • North Carolina
    • Raleigh, North Carolina, United States, 27612

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult male or female ambulatory outpatient age 19 or older.
• Patients meet ROME II Criteria
• Patients not meeting ROME IBS criteria
• Use of a constipating medication (>= 3% in PDR)
• 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
• Written informed consent.

Exclusion Criteria:

• Known or suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease.
• Prior small bowel or colonic resection or colostomy.
• Weight < 80 lbs.
• Unwilling or unable to undergo any colon diagnostic examinations at the end of the study if not performed within 5 years of the informed consent date advised by clinically accepted indications.
• Positive stool hemoccult.
• Significant cardiac, renal or hepatic insufficiency.
• Pregnant or expecting to become pregnant within 120 days of study enrollment.
• Lactating or breast feeding.
• Subjects who in the opinion of the investigator would be unable to comply adequately with the study plan.
• Use of investigational drugs in the last 30 days.
• Patients with known allergy to PEG or PEG medications such as PEG or sulfate-free electrolyte lavage solutions

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Analysis of individual ROME I criteria
Safety (adverse event and laboratory testing)

Collaborators and Investigators

• Sponsor: Braintree Laboratories
• Investigators: Principal Investigator: Jorge Herrera, MD, University of South Alabama

Study record dates

Study Major Dates

• Study Start: November 1, 2001
• Primary Completion (Actual): September 1, 2004

Study Registration Dates

• First Submitted: September 7, 2005
• First Submitted That Met QC Criteria: September 7, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Estimate): February 7, 2013
• Last Update Submitted That Met QC Criteria: February 6, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Gastrointestinal Agents; Laxatives; Polyethylene glycol 3350
• Other Study ID Numbers: 851-17