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

This study has been completed.
Sponsor:
Information provided by:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00153127
First received: September 7, 2005
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Constipation
Drug: polyethyleneglycol3350
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Comparison of Braintree PolyethyleneGlycol(PEG) Laxative and Placebo for Relief of Constipation From Constipating Medications

Resource links provided by NLM:


Further study details as provided by Braintree Laboratories:

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 event and laboratory testing)

Estimated Enrollment: 100
Study Start Date: November 2001
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153127

Locations
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
Investigators
Principal Investigator: Jorge Herrera, MD University of South Alabama
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00153127     History of Changes
Other Study ID Numbers: 851-17
Study First Received: September 7, 2005
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 27, 2014