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

November 22, 2010 updated by: Synergy Health Solutions

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

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.

Study Overview

Status

Withdrawn

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Nursing Home Residents (adult subjects living in Nursing Homes)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Lubiprostone Subjects switching from current bowel medicines to lubiprostone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	60 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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	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	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	60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synergy Health Solutions

Investigators

Principal Investigator: Malcolm R Fraser, MD, Synergy Health Solutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

April 1, 2010

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

September 24, 2009

First Submitted That Met QC Criteria

September 25, 2009

First Posted (Estimate)

September 28, 2009

Study Record Updates

Last Update Posted (Estimate)

November 23, 2010

Last Update Submitted That Met QC Criteria

November 22, 2010

Last Verified