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

Mylan

Status: Completed

Conditions: Pancreatic Diseases; Digestive System Diseases; Exocrine Pancreatic Insufficiency

Treatments: Drug: Lipacreon

Study type: Observational

Funder types: Industry

Identifiers

NCT01427725

P12-894

Details and patient eligibility

About

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.

Full 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

Enrollment: 579 patients

Sex: All

Ages: 1 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

579 participants in 1 patient group

Lipacreon

Description:

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.

Treatment:

Drug: Lipacreon