A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy
NCT ID: NCT00414908
Last Updated: 2011-08-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
52 participants
INTERVENTIONAL
2007-10-31
2009-12-31
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 capsule
24,000 unit capsule
B
Placebo Comparator
Placebo
Interventions
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Pancrelipase delayed release capsule
24,000 unit capsule
Placebo Comparator
Placebo
Eligibility Criteria
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Inclusion Criteria
* Direct or indirect pancreatic function test (except stool fat excretion) or Clinical signs of severe steatorrhoea that resolved upon administration of pancreatic supplementation.
* Total stool fat \> 40 g over 4 days (using Van De Kamer method)
* Proven chronic pancreatitis
* Females of child-bearing potential must agree to continue using a medically acceptable method of birth control
Exclusion Criteria
* Any type of malignancy involving the digestive tract in the last 5 years
* Presence of pseudo-pancreatic cyst ≥ 4
* Continued excessive intake of alcohol or drug abuse
* Known infection with HIV
18 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 9
Scottsdale, Arizona, United States
Site 22
Bristol, Connecticut, United States
Site 7
Tampa, Florida, United States
Site 6
Atlanta, Georgia, United States
Site 17
Chicago, Illinois, United States
Site 30
Maywood, Illinois, United States
Site 14
Indianapolis, Indiana, United States
Site 15
Kansas City, Kansas, United States
Site 16
Lexington, Kentucky, United States
Site 12
New Orleans, Louisiana, United States
Site 3
Boston, Massachusetts, United States
Site 2
Ann Arbor, Michigan, United States
Site 29
Grand Rapids, Michigan, United States
Site 1
Tupelo, Mississippi, United States
Site 5
St Louis, Missouri, United States
Site 8
Cedar Knolls, New Jersey, United States
Site 20
Boone, North Carolina, United States
Site 4
Rutherford College, North Carolina, United States
Site 10
Cincinnati, Ohio, United States
Site 11
Cleveland, Ohio, United States
Site 21
Pittsburgh, Pennsylvania, United States
Site 13
Dallas, Texas, United States
Site 18
Richmond, Virginia, United States
Site 23
Sofia, , Bulgaria
Site 27
Warsaw, , Poland
Site 19
San Juan, , Puerto Rico
Site 25
Saint Petersburg, , Russia
Site 26
Belgrade, , Serbia
Site 24
Cape Town, , South Africa
Site 28
Kiev, , Ukraine
Countries
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Other Identifiers
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2004-000227-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
S245.3.124
Identifier Type: -
Identifier Source: org_study_id
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