NCT Number: NCT00153127
Comparison of PolyethyleneGlycol 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.
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Conditions
Age range
19 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Mobile, Alabama, United States
Who can participate
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
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)
Sponsors and collaborators
Lead sponsor
Braintree Laboratories
Industry
Registry information
Official study title
Comparison of Braintree PolyethyleneGlycol(PEG) Laxative and Placebo for Relief of Constipation From Constipating Medications
Important dates
- Study start
- 2001
- Primary completion
- 2004
- First posted
- Sep 12, 2005
- Registry last updated
- Feb 7, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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