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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4

Details

• Lead Sponsor: Braintree Laboratories
• Treatments: Polyethylene glycol 3350

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