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Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency

Digestive System Diseases Clinical Trial

Official title:
Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis, Pancreatectomy and Other Conditions Except Cystic Fibrosis

Clinical Trial 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 to evaluate the effective and safe use of LipaCreon.

Clinical Trial 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 cholesterol - Triglycerides - Haemoglobin 3. Symptoms related to exocrine pancreatic insufficiency - Steatorrhoea - Frequency of bowel movements - Diarrhoea - Foul stool odour - Decreased appetite - Abdominal distension 4. Patient's quality of life (QOL) 5. Degree of general improvement ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01427725
Study type Observational
Source Viatris Inc.
Contact
Status Completed
Phase
Start date September 2011
Completion date April 2015
View Details
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