Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
NCT ID: NCT01427712
Last Updated: 2022-06-10
Study Results
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View full resultsBasic Information
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COMPLETED
24 participants
OBSERVATIONAL
2011-08-31
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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LipaCreon
In general, pancrelipase 600 mg/dose was orally administered immediately after a meal, 3 times a day.
Also, the dose was adjusted appropriately according to the patient's condition.
Pancrelipase
Interventions
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Pancrelipase
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with a history of hypersensitivity to porcine protein
1 Year
99 Years
ALL
No
Sponsors
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Mylan Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Shigenori Haruna
Role: STUDY_DIRECTOR
Mylan EPD G.K.
Locations
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Site Reference ID/Investigator# 73813
Aichi, , Japan
Site reference ID/Investigator # 96698
Aichi, , Japan
Research facility ID ORG-000141
Aichi, , Japan
Site reference ID/Investigator no. ORG-000842
Aichi, , Japan
Site reference ID/Investigator # 93736
Aichi, , Japan
Research facility ORG-000972
Ehime, , Japan
Mylan investigational site A
Hyōgo, , Japan
Site reference ID/Investigator # 93735
Ibaraki, , Japan
Site Reference ID/Investigator# 88673
Ibaraki, , Japan
Site Reference ID/Investigator# 65529
Ishikawa, , Japan
Site Reference ID/Investigator# 65530
Kagawa, , Japan
Site Reference ID/Investigator# 65527
Kagoshima, , Japan
Mylan investigational site C
Kanagawa, , Japan
Site Reference ID/Investigator# 65528
Miyagi, , Japan
Mylan investigational site B
Miyagi, , Japan
Research facility ID ORG-000594
Osaka, , Japan
Research facility ID ORG-001138
Ōita, , Japan
Research facility ORG-000971
Shizuoka, , Japan
Site reference ID/Investigator# 117495
Tochigi, , Japan
Research facility no. ORG-001309
Tokyo, , Japan
Site Reference ID/Investigator# 67122
Tokyo, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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P12-893
Identifier Type: -
Identifier Source: org_study_id
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