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

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

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