ConstipationSTOOLNCT00985569
Surveying The Outcomes Of Lubiprostone (The STOOL Study) in Nursing Home Residents
An observational study of Constipation, run by Synergy Health Solutions at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- How many people
- 105 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2009to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Nursing Home Residents (adult subjects living in Nursing Homes)
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Geriatric Medical Associates
Brooksville, Florida
Cassellberry Family Practice
Casselberry, Florida
Osler Geriatrics
Melbourne, Florida
About this study
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
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.
Read the 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.
- Conditions
- Constipation
- Keywords
- Constipation, Nursing Home, Quality Indicator
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lubiprostone | Subjects switching from current bowel medicines to lubiprostone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the overall reduction in the number of oral medicines taken by each NH resident at enrollment and at 60 days.
Measured: 60 days
Secondary outcomes (3)
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)
Measured: 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)
Measured: 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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2010 (estimated)
- Study completionNov 2010 (estimated)
Why it stopped: Enrollment was never begun.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synergy Health Solutions
- Sponsor type
- University, hospital or other
- Investigators
- Malcolm R Fraser, MD, Principal investigator, Synergy Health Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985569
- Sponsor's protocol ID
- STOOL
- Acronym
- STOOL
- Status last verified
- Nov 2010
- First submitted
- 24 Sep 2009
- Last updated
- 23 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00985569
- Acronym / sponsor ID
- STOOL / STOOL
- Conditions
- Constipation
- Keywords
- Constipation, Nursing Home, Quality Indicator
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Enrollment was never begun.
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Synergy Health SolutionsUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 28 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lubiprostone | – | –Subjects switching from current bowel medicines to lubiprostone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nursing Home Residents (adult subjects living in Nursing Homes)
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (11 listed)
- Currently pregnant;
- Presence of megacolon;
- Presence of rectal sigmoid cancer;
- Presence of colon cancer;
- Presence of anal incompetence;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm R Fraser, MD principal investigator
Synergy Health Solutions
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation, run by Synergy Health Solutions at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2010.