Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis
Completed · Not applicable
Conditions studied: Constipation, Cystic Fibrosis
In brief
The purpose of this study is to determine the short term safety and effectiveness of lubiprostone when used for constipation in adults with cystic fibrosis.
Key facts
- Study ID
- NCT00706004
- Run by
- University of Arkansas
- People needed
- 9
- Starts
- 2008-07-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2011-04-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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