Surveying The Outcomes Of Lubiprostone (The STOOL Study) in Nursing Home Residents (STOOL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00985569|
Recruitment Status : Withdrawn (Enrollment was never begun.)
First Posted : September 28, 2009
Last Update Posted : November 23, 2010
|Condition or disease|
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 protocol using standardizes definitions in which eligible patients will be asked to participate in the proposed study. During the course of the study, various selected parameters will be measured and compared to establish the clinical efficacy of Lubiprostone in the treatment of CIC.
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.
|Study Type :||Observational|
|Estimated Enrollment :||105 participants|
|Official Title:||Surveying The Outcomes Of Lubiprostone (The STOOL Study): The Effect of Lubiprostone on Reducing the Number of Medications Prescribed to Nursing Home Residents and Its Impact on Selected Quality Indicators|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||April 2010|
|Estimated Study Completion Date :||November 2010|
Subjects switching from current bowel medicines to lubiprostone
- To determine the overall reduction in the number of oral medicines taken by each NH resident at enrollment and at 60 days. [ Time Frame: 60 days ]
- 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) [ Time Frame: 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) [ Time Frame: 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. [ Time Frame: 60 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985569
|United States, Florida|
|Geriatric Medical Associates|
|Brooksville, Florida, United States|
|Cassellberry Family Practice|
|Casselberry, Florida, United States|
|Melbourne, Florida, United States|
|Principal Investigator:||Malcolm R Fraser, MD||Synergy Health Solutions|