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

Constipation Clinical Trial

— STOOL  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00985569
• Other study ID #: STOOL
• Status: Withdrawn
• Phase: N/A
• First received: September 24, 2009
• Last updated: November 22, 2010
• Start date: November 2009
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: Synergy Health Solutions
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 105
• Est. completion date: November 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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 Criteria:

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Constipation

Locations

Country	Name	City	State
United States	Geriatric Medical Associates	Brooksville	Florida
United States	Cassellberry Family Practice	Casselberry	Florida
United States	Osler Geriatrics	Melbourne	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Synergy Health Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the overall reduction in the number of oral medicines taken by each NH resident at enrollment and at 60 days.		60 days	No
Secondary	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)		60 days	No
Secondary	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)		60 days	No
Secondary	To compare the occurrence of fecal incontinence during a 60-day period prior to initiating Lubiprostone with a 60 day period after initiating Lubiprostone.		60 days	No