Surveying The Outcomes Of Lubiprostone (The STOOL Study) in Nursing Home Residents
NCT ID: NCT00985569
Last Updated: 2010-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
105 participants
OBSERVATIONAL
2009-11-30
2010-11-30
Brief Summary
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Detailed Description
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The study sample (N=105) will be comprised of nursing home residents with a confirmed diagnosis of CIC. A power analysis generated a sample size of 97 residents. To protect the validity of the test, 8 residents were added to the final study sample to allow for losses to followup. Therefore, a final sample size of 105 residents was identified for the study.
Patients meeting the inclusion criteria will be recruited for participation in the study. 3 sites in Central Florida with multiple Nursing Homes per site will be recruited to participate in the proposed study.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Lubiprostone
Subjects switching from current bowel medicines to lubiprostone
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Synergy Health Solutions
OTHER
Responsible Party
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Synergy Health Solutions
Principal Investigators
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Malcolm R Fraser, MD
Role: PRINCIPAL_INVESTIGATOR
Synergy Health Solutions
Locations
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Geriatric Medical Associates
Brooksville, Florida, United States
Cassellberry Family Practice
Casselberry, Florida, United States
Osler Geriatrics
Melbourne, Florida, United States
Countries
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Other Identifiers
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STOOL
Identifier Type: -
Identifier Source: org_study_id