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OpenTrials
Completed

NCT Number: NCT00153127

Comparison of PolyethyleneGlycol 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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mobile, Alabama, United States

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

polyethyleneglycol3350

Drug

Primary outcomes

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

Secondary outcomes

  1. Analysis of individual ROME I criteria

  2. Safety (adverse event and laboratory testing)

Sponsors and collaborators

Lead sponsor

Braintree Laboratories

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2004
First posted
Sep 12, 2005
Registry last updated
Feb 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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