Title

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
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    100
The purpose of this study is to assess treatment responses comparing a newly FDA-approved PEG laxative versus placebo.
Study Started
Nov 30
2001
Primary Completion
Sep 30
2004
Last Update
Feb 07
2013
Estimate

Drug polyethyleneglycol3350

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
No Results Posted