Status:
WITHDRAWN
Surveying The Outcomes Of Lubiprostone (The STOOL Study) in Nursing Home Residents
Lead Sponsor:
Synergy Health Solutions
Conditions:
Constipation
Eligibility:
All Genders
18+ years
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 chron...
Detailed Description
The study is a prospective, observational, open-label, non-placebo, controlled study to measure the effects of Lubiprostone on CIC in nursing home residents. All clinical sites will follow a common pr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00985569
Start Date
November 1 2009
End Date
November 1 2010
Last Update
November 23 2010
Active Locations (3)
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1
Geriatric Medical Associates
Brooksville, Florida, United States
2
Cassellberry Family Practice
Casselberry, Florida, United States
3
Osler Geriatrics
Melbourne, Florida, United States