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

This study has been withdrawn prior to enrollment.
(Enrollment was never begun.)
Sponsor:
Information provided by:
Synergy Health Solutions
ClinicalTrials.gov Identifier:
NCT00985569
First received: September 24, 2009
Last updated: November 22, 2010
Last verified: November 2010
  Purpose

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.


Condition
Constipation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Synergy Health Solutions:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 105
Study Start Date: November 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Lubiprostone
Subjects switching from current bowel medicines to lubiprostone

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Nursing Home Residents (adult subjects living in Nursing Homes)

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985569

Locations
United States, Florida
Geriatric Medical Associates
Brooksville, Florida, United States
Cassellberry Family Practice
Casselberry, Florida, United States
Osler Geriatrics
Melbourne, Florida, United States
Sponsors and Collaborators
Synergy Health Solutions
Investigators
Principal Investigator: Malcolm R Fraser, MD Synergy Health Solutions
  More Information

No publications provided

Responsible Party: Malcolm Fraser, MD, CMD, Synergy Health Solutions
ClinicalTrials.gov Identifier: NCT00985569     History of Changes
Other Study ID Numbers: STOOL
Study First Received: September 24, 2009
Last Updated: November 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Synergy Health Solutions:
Constipation
Nursing Home
Quality Indicator

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014