NCT01427725

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 579 (actual)
• Sponsor: Mylan Inc. · Industry
• Sex: All
• Age: 1 Year – 99 Years
• Healthy volunteers: Not accepted

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.

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 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

Conditions

• Exocrine Pancreatic Insufficiency
• Pancreatic Diseases
• Digestive System Diseases

Interventions

Type	Name	Description
DRUG	Lipacreon	This study was an observational study and no intervention was specified

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-01-01
• Completion: 2015-04-01
• First posted: 2011-09-02
• Last updated: 2022-06-13
• Results posted: 2022-06-13

Locations

189 sites across 1 country: Japan