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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00153127
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : February 7, 2013
Information provided by:
Braintree Laboratories

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

Condition or disease Intervention/treatment Phase
Constipation Drug: polyethyleneglycol3350 Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Comparison of Braintree PolyethyleneGlycol(PEG) Laxative and Placebo for Relief of Constipation From Constipating Medications
Study Start Date : November 2001
Actual Primary Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

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 and laboratory testing)

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00153127

United States, Alabama
Mobile, Alabama, United States, 36693
United States, Florida
St. Petersburg, Florida, United States, 33707
United States, Missouri
St. Louis, Missouri, United States, 63141
United States, North Carolina
Raleigh, North Carolina, United States, 27612
Sponsors and Collaborators
Braintree Laboratories
Principal Investigator: Jorge Herrera, MD University of South Alabama Identifier: NCT00153127     History of Changes
Other Study ID Numbers: 851-17
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Polyethylene glycol 3350
Gastrointestinal Agents