Comparison of PolyethyleneGlycol and Placebo for Relief of Constipation From Constipating Medications
Completed · Phase 4
Conditions studied: Constipation
In brief
The purpose of this study is to assess treatment responses comparing a newly FDA-approved PEG laxative versus placebo.
Key facts
- Study ID
- NCT00153127
- Run by
- Braintree Laboratories
- People needed
- 100
- Starts
- 2001-11-01
- Last updated by the study team
- 2013-02-07
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Study site — Mobile, Alabama, United States
- Study site — St. Petersburg, Florida, United States
- Study site — St Louis, Missouri, United States
- Study site — Raleigh, North Carolina, United States
Full record on ClinicalTrials.gov
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