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

Condition	Intervention	Phase
Constipation	Drug: polyethyleneglycol3350	Phase IV

Further Study Details: 

Primary Outcomes: A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria
Secondary Outcomes: Analysis of individual ROME I criteria; Safety (adverse event and laboratory testing)
Expected Total Enrollment:  100

Ages Eligible for Study:  19 Years and above,  Genders Eligible for Study:  Both

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

Alabama
      Mobile,  Alabama,  36693,  United States
Florida
      St. Petersburg,  Florida,  33707,  United States
Missouri
      St. Louis,  Missouri,  63141,  United States
North Carolina
      Raleigh,  North Carolina,  27612,  United States

Study chairs or principal investigators

Jorge Herrera, MD,  Principal Investigator,  University of South Alabama   

Study ID Numbers:  851-17
Last Updated:  September 9, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00153127
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13