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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Brief Summary

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

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Detailed Description

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Conditions

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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polyethyleneglycol3350

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No