Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-03 @ 2:43 AM
Study NCT ID:
NCT00985569
Status:
WITHDRAWN
Last Update Posted:
2010-11-23
First Post:
2009-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surveying The Outcomes Of Lubiprostone (The STOOL Study) in Nursing Home Residents
Sponsor:
Synergy Health Solutions
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment was never begun.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STOOL
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.
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 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: