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

Synergy Health Solutions

Status: Withdrawn

Conditions: Constipation

Study type: Observational

Funder types: Other

Identifiers

NCT00985569

STOOL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

105 participants in 1 patient group

Lubiprostone

Description:

Subjects switching from current bowel medicines to lubiprostone