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
1 other identifier
interventional
100
1 country
4
Brief Summary
The purpose of this study is to assess treatment responses comparing a newly FDA-approved PEG laxative versus placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedFebruary 7, 2013
February 1, 2013
2.8 years
September 7, 2005
February 6, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
A successful outcome is defined as no longer meeting the definition of constipation using ROME I criteria
Secondary Outcomes (2)
Analysis of individual ROME I criteria
Safety (adverse event and laboratory testing)
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Unknown Facility
Mobile, Alabama, 36693, United States
Unknown Facility
St. Petersburg, Florida, 33707, United States
Unknown Facility
St Louis, Missouri, 63141, United States
Unknown Facility
Raleigh, North Carolina, 27612, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jorge Herrera, MD
University of South Alabama
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 12, 2005
Study Start
November 1, 2001
Primary Completion
September 1, 2004
Last Updated
February 7, 2013
Record last verified: 2013-02