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Status:

COMPLETED

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

Lead Sponsor:

Braintree Laboratories

Conditions:

Constipation

Eligibility:

All Genders

19+ years

Phase:

PHASE4

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2001

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00153127

Start Date

November 1 2001

Last Update

February 7 2013

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Mobile, Alabama, United States, 36693

2

St. Petersburg, Florida, United States, 33707

3

St Louis, Missouri, United States, 63141

4

Raleigh, North Carolina, United States, 27612