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

Mylan

Status: Completed

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

Treatments: Drug: Pancrelipase

Study type: Observational

Funder types: Industry

Identifiers

NCT01427712

P12-893

Details and patient eligibility

About

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 order to evaluate the effective and safe use of LipaCreon.

Enrollment: 24 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 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

Trial design

24 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: Pancrelipase