Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
NCT ID: NCT00510484
Last Updated: 2010-06-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
35 participants
INTERVENTIONAL
2007-11-30
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
Pancrelipase Delayed Release
24000 unit Capsule
B
Placebo Comparator
Placebo
Interventions
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Pancrelipase Delayed Release
24000 unit Capsule
Placebo Comparator
Placebo
Eligibility Criteria
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Inclusion Criteria
* Confirmed PEI by historical CFA \< 70% without supplementation or current or historical fecal elastase \< 50µg/g stool (within the last 12 months)
* Subjects of 12 years or older
* Currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months
* Clinically stable condition without evidence of acute respiratory disease or any other acute condition
* Females of child-bearing potential must agree to continue using a medically acceptable method of birth control
Exclusion Criteria
* History of fibrosing colonopathy
* History of distal ileal obstruction syndrome within 6 months of enrollment
* Use of an immunosuppressive drug
* Any type of malignancy involving the digestive tract in the last 5 years
* Known infection with HIV
12 Years
ALL
No
Sponsors
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Solvay Pharmaceuticals
INDUSTRY
Responsible Party
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Solvay Pharmaceuticals
Principal Investigators
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Global Clinical Director Solvay
Role: STUDY_DIRECTOR
Solvay Pharmaceuticals
Locations
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Site 11
Long Beach, California, United States
Site 10
Los Angeles, California, United States
Site 13
San Francisco, California, United States
Site 5
Miami, Florida, United States
Site 4
Orlando, Florida, United States
Site 1
Iowa City, Iowa, United States
Site 7
Louisville, Kentucky, United States
Site 17
Boston, Massachusetts, United States
Site 8
Ann Arbor, Michigan, United States
Site 6
Minneapolis, Minnesota, United States
Site 18
Long Branch, New Jersey, United States
Site 16
Albuquerque, New Mexico, United States
Site 19
Cincinnati, Ohio, United States
Site 12
Dayton, Ohio, United States
Site 2
Toledo, Ohio, United States
Site 14
Oklahoma City, Oklahoma, United States
Site 3
Hershey, Pennsylvania, United States
Site 15
Philadelphia, Pennsylvania, United States
Site 9
Nashville, Tennessee, United States
Site 20
Petrofi, , Hungary
Site 21
Jerusalem, , Israel
Site 22
Johannesburg, , South Africa
Site 23
Barcelona, , Spain
Countries
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References
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Trapnell BC, Maguiness K, Graff GR, Boyd D, Beckmann K, Caras S. Efficacy and safety of Creon 24,000 in subjects with exocrine pancreatic insufficiency due to cystic fibrosis. J Cyst Fibros. 2009 Dec;8(6):370-7. doi: 10.1016/j.jcf.2009.08.008. Epub 2009 Oct 7.
Other Identifiers
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2007-004005-10
Identifier Type: -
Identifier Source: secondary_id
S245.3.126
Identifier Type: -
Identifier Source: org_study_id
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