Status:

COMPLETED

Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Lead Sponsor:

Mylan Inc.

Conditions:

Cystic Fibrosis

Exocrine Pancreatic Insufficiency

Eligibility:

All Genders

1-99 years

Brief Summary

This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients due to cystic fibrosis receiving the treatment with LipaCreon in...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency due to cystic fibrosis
  • Exclusion Criteria
  • Patients with a history of hypersensitivity to the ingredient of LipaCreon.
  • Patients with a history of hypersensitivity to porcine protein

Exclusion

    Key Trial Info

    Start Date :

    August 1 2011

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2018

    Estimated Enrollment :

    24 Patients enrolled

    Trial Details

    Trial ID

    NCT01427712

    Start Date

    August 1 2011

    End Date

    March 1 2018

    Last Update

    June 10 2022

    Active Locations (21)

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    Page 1 of 6 (21 locations)

    1

    Site Reference ID/Investigator# 73813

    Aichi, Japan, 462-8508

    2

    Site reference ID/Investigator # 96698

    Aichi, Japan, 466-8650

    3

    Research facility ID ORG-000141

    Aichi, Japan, 467-8602

    4

    Site reference ID/Investigator no. ORG-000842

    Aichi, Japan, 470-0224