Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT00706004
Eligibility Criteria:
Inclusion Criteria:
* Men and women of all races
* 18 years of age or older at time of enrollment
* Diagnosis of cystic fibrosis
* History of constipation, as defined by the Rome III criteria, OR the requirement of chronic scheduled doses of a laxative, OR a score ≥1.5 on the Patient assessment of constipation symptoms (PAC-SYM)15 survey administered during the screening visit, OR a score of less than 3 on the Bristol Stool Scale (BSS) at the screening visit.
Exclusion Criteria:
* Current gastrointestinal (GI) obstruction
* History of GI obstruction requiring hospitalization within six months of enrollment
* Pregnancy or breastfeeding
* Hypersensitivity to lubiprostone or any of its components
* Serum creatinine \>1.8 mg/dL at last annual visit
* Clinically significant liver disease, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3X upper limit of normal
* History of frequent hospital admissions for CF exacerbations (≥4 in the last 6 months)
* Currently registered on a lung transplant waiting list
* Women of capable of child-bearing who either refuse a pregnancy test, or are incapable or unwilling to use contraception during the protocol, or both.
* Any other condition, in the opinion of the investigators, that interferes with the ability of the participant to comply with study requirements, confers significant risk to the participant, or limits the ability of the participant to complete the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00706004
Study Brief:
Protocol Section:
NCT00706004