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

NCT00706004 | Completed Results

• 1 other identifier: 76992
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation; Cystic Fibrosis

Keywords

constipation; cystic fibrosis; lubiprostone; Constipation in adults with cystic fibrosis

Outcome Measures

Primary Outcomes (1)

• Number of Spontaneous Bowel Movements Per Week

  2-week run-in period, 2-weeks of treatment, 4-weeks of treatment

Secondary Outcomes (21)

• Patient Assessment of Constipation Symptoms

  2-week run-in period, 2 weeks of treatment, 4 weeks of treatment

• Bristol Stool Scale Score

  2-week run-in period, 2 weeks of treatment, 4 weeks of treatment

• Body Mass Index

  baseline, 2 weeks of treatment, 4 weeks of treatment

• Self Reported Adverse Effects at Each Study Visit

  During entire study period

• Serum Sodium

  baseline, 4 weeks

Interventions

lubiprostone DRUG

lubiprostone 24 microgram capsule taken twice daily for 4 weeks

Also known as: Brand name: Amitiza

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women of all races
• 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

Sponsors & Collaborators

• University of Arkansas: lead
• Takeda Pharmaceuticals North America, Inc.: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Constipation; Cystic Fibrosis

Interventions

Lubiprostone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Results Point of Contact

• Title: Catherine O'Brien
• Organization: University of Arkansas for Medical Sciences

obriencatherinee@uams.edu

501-364-1828

Study Officials

• Catherine E. O'Brien, Pharm.D.

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 25, 2008
• First Posted: June 27, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 18, 2011
• Results First Posted: April 18, 2011

Record last verified: 2011-03

Locations

US (1)