Status:
COMPLETED
Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis
Lead Sponsor:
University of Arkansas
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
Conditions:
Constipation
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
Cystic fibrosis (CF) affects about 30,000 people in the United States. It is caused by an absent or dysfunctional protein called CF transmembrane conductance regulator (CFTR) which functions as a chlo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00706004
Start Date
July 1 2008
End Date
December 1 2009
Last Update
April 18 2011
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205