Surveying The Outcomes Of Lubiprostone (The STOOL Study) in Nursing Home Residents

Withdrawn before enrolling

Conditions studied: Constipation

In brief

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.

Key facts

Study ID

NCT00985569

Run by

Synergy Health Solutions

People needed

105

Starts

2009-11-01

Expected to finish

2010-11-01

Last updated by the study team

2010-11-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Geriatric Medical Associates — Brooksville, Florida, United States
• Cassellberry Family Practice — Casselberry, Florida, United States
• Osler Geriatrics — Melbourne, Florida, United States

Full record on ClinicalTrials.gov

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