Study Stopped
Enrollment was never begun.
Surveying The Outcomes Of Lubiprostone (The STOOL Study) in Nursing Home Residents
STOOL
1 other identifier
observational
105
1 country
3
Brief Summary
The purpose is to assess the efficacy, clinical outcomes, and potential Quality Indicator benefits associated with the use of Lubiprostone in nursing home residents with a confirmed diagnosis of chronic idiopathic constipation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2009
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2009
CompletedFirst Posted
Study publicly available on registry
September 28, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedNovember 23, 2010
November 1, 2010
5 months
September 24, 2009
November 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the overall reduction in the number of oral medicines taken by each NH resident at enrollment and at 60 days.
60 days
Secondary Outcomes (3)
Reduce the number of oral medicines being taken by any nursing home resident from 9 or more to fewer than 9. (Quality Indicator Number 6)
60 days
To compare the occurrence of fecal impaction during a 60-day period prior to initiating Lubiprostone with a 60 day period after initiating Lubiprostone. (Quality Indicator Number 11)
60 days
To compare the occurrence of fecal incontinence during a 60-day period prior to initiating Lubiprostone with a 60 day period after initiating Lubiprostone.
60 days
Study Arms (1)
Lubiprostone
Subjects switching from current bowel medicines to lubiprostone
Eligibility Criteria
Nursing Home Residents (adult subjects living in Nursing Homes)
You may qualify if:
- Patients must meet all of the following criteria to be eligible for the study:
- Adult men and women nursing home residents;
- Confirmed diagnosis of CIC using Rome criteria;
- Prescribed two or more laxatives, at recruitment;
- Taking 9 or more oral medicines (including prescription, OTC and prn)
- Free from conditions likely to be fatal within six months;
- Able to read or understand English; and
- Able and willing to provide informed consent or has a guardian/agent who can provide consent.
You may not qualify if:
- Currently pregnant;
- Presence of megacolon;
- Presence of rectal sigmoid cancer;
- Presence of colon cancer;
- Presence of anal incompetence;
- Conditions likely to be fatal within six months;
- Taking 8 or fewer medicines;
- Enrolled in hospice;
- Non-English speaking patients; and
- Unwilling or unable to provide informed consent and has no guardian/agent.
- Expected to be discharged within 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Geriatric Medical Associates
Brooksville, Florida, United States
Cassellberry Family Practice
Casselberry, Florida, United States
Osler Geriatrics
Melbourne, Florida, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Malcolm R Fraser, MD
Synergy Health Solutions
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 24, 2009
First Posted
September 28, 2009
Study Start
November 1, 2009
Primary Completion
April 1, 2010
Study Completion
November 1, 2010
Last Updated
November 23, 2010
Record last verified: 2010-11