Status:
COMPLETED
Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency
Lead Sponsor:
Mylan Inc.
Conditions:
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
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 receiving the treatment with LipaCreon for a long term in order ...
Detailed Description
Criteria for evaluation: 1. Adverse events 2. Nutritional endpoints * BMI (height \[only prior to the start of Lipacreon treatment\] and weight) * Serum total protein * Albumin * Total c...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency
- 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 :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
579 Patients enrolled
Trial Details
Trial ID
NCT01427725
Start Date
September 1 2011
End Date
April 1 2015
Last Update
June 13 2022
Active Locations (189)
Enter a location and click search to find clinical trials sorted by distance.
1
Research facility ID ORG-000247
Aichi, Japan, 440-0014
2
Research facility ID ORG-000216
Aichi, Japan, 444-8553
3
Research facility ID ORG-000214
Aichi, Japan, 448-8505
4
Research facility ID ORG-000215
Aichi, Japan, 448-8505