Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arkansas
• Collaborator: Takeda Pharmaceuticals North America, Inc.
• Treatments: Lubiprostone

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