Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
58 participants
INTERVENTIONAL
2008-04-30
2011-06-30
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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1
Creon
3 capsules Creon with 25000 lipase units per main meal (3 main meals) plus 2 capsules per snack (2-3 snacks)
2
Placebo
Placebo
Interventions
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Creon
3 capsules Creon with 25000 lipase units per main meal (3 main meals) plus 2 capsules per snack (2-3 snacks)
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Direct or indirect pancreatic function test (except stool fat excretion) and
* Steatorrhoea: stool fat \> 15 g/day (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
* Ileus or acute abdomen
* Current excessive intake of alcohol or drug abuse
* Hypersensitivity vs porcine proteins / pancreatin
* Subjects taking digestive enzyme preparations have to stop them before start of the run-in period
18 Years
ALL
No
Sponsors
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Quintiles, Inc.
INDUSTRY
Data Map GmbH
UNKNOWN
Abbott Products
INDUSTRY
Responsible Party
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Abbott Products
Principal Investigators
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Guenter Krause, MD
Role: STUDY_DIRECTOR
Abbott Products
Locations
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Site Reference ID/Investigator# 45022
Rousse, , Bulgaria
Site Reference ID/Investigator# 45020
Sofia, , Bulgaria
Site Reference ID/Investigator# 45026
Greifswald, , Germany
Site Reference ID/Investigator# 45025
Hamburg, , Germany
Site Reference ID/Investigator# 45027
Heidelberg, , Germany
Site Reference ID/Investigator# 45024
Munich, , Germany
Site Reference ID/Investigator# 45126
Békéscsaba, , Hungary
Site Reference ID/Investigator# 45121
Budaörs, , Hungary
Site Reference ID/Investigator# 45127
Dunaújváros, , Hungary
Site Reference ID/Investigator# 45115
Gyula, , Hungary
Site Reference ID/Investigator# 45116
Sopron, , Hungary
Site Reference ID/Investigator# 45114
Szeged, , Hungary
Site Reference ID/Investigator# 45130
Bologna, , Italy
Site Reference ID/Investigator# 45129
Padua, , Italy
Site Reference ID/Investigator# 45128
Verona, , Italy
Countries
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Other Identifiers
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2005-004854-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
S245.4.008
Identifier Type: -
Identifier Source: org_study_id
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