Status:
COMPLETED
Comparison of PolyethyleneGlycol and Placebo for Relief of Constipation From Constipating Medications
Lead Sponsor:
Braintree Laboratories
Conditions:
Constipation
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess treatment responses comparing a newly FDA-approved PEG laxative versus placebo.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00153127
Start Date
November 1 2001
Last Update
February 7 2013
Active Locations (4)
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1
Mobile, Alabama, United States, 36693
2
St. Petersburg, Florida, United States, 33707
3
St Louis, Missouri, United States, 63141
4
Raleigh, North Carolina, United States, 27612