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

NCT ID: NCT00706004

Last Updated: 2011-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-12-31

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 chloride channel. Lubiprostone is a medication indicated for constipation that activates type 2 chloride channels (ClC-2) and has the potential to be an effective treatment for constipation in adults with CF. It has the potential to correct the underlying disorder by utilizing a chloride channel whose activity does not depend on CFTR. This project is a prospective open-label pilot study to examine the safety and effectiveness of lubiprostone when used in adults with CF with constipation. The specific aims are as follows: 1) Determine the effectiveness of lubiprostone for constipation in participants with CF, and 2) Determine the short term safety of lubiprostone in adults with CF. Data will also be collected to generate further information about the effect of lubiprostone on nutritional status.

Conditions

Constipation; Cystic Fibrosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

lubiprostone

lubiprostone 24 microgram capsule taken twice daily for 4 weeks

Intervention Type: DRUG

Other Intervention Names

Brand name: Amitiza

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda Pharmaceuticals North America, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

University of Arkansas for Medical Sciences

Principal Investigators

Catherine E. O'Brien, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

76992

Identifier Type: -

Identifier Source: org_study_id