Male and female patients aged ≥ 18 to ≤ 85 years with a total pancreatectomy with Pancreatic Exocrine Insufficiency (PEI).
Conditions
Brief summary
Percentage of patients treated with higher than approved final treatment doses.
Detailed description
CGI (investigator), Nutritional laboratory parameters, Diabetes parameters (glucose and HbA1c levels, insulin doses), Clinical symptoms (abdominal pain, flatulence, stool consistency; diary), stool frequency, average daily stool frequency during treatment period (diary), time course, Body Mass Index (BMI) and body weight, Improvement in Quality of Life (QoL), Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q), change from baseline to end of treatment, Evaluation of vital signs, Incidence of Adverse Events (AEs) – PERT related
Interventions
DRUGKreon 35 000 Ph. Eur. Lipase Einheiten
DRUGmagensaftresistente Hartkapseln
Sponsors
MEDA Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients treated with higher than approved final treatment doses. | — |
Secondary
| Measure | Time frame |
|---|---|
| CGI (investigator), Nutritional laboratory parameters, Diabetes parameters (glucose and HbA1c levels, insulin doses), Clinical symptoms (abdominal pain, flatulence, stool consistency; diary), stool frequency, average daily stool frequency during treatment period (diary), time course, Body Mass Index (BMI) and body weight, Improvement in Quality of Life (QoL), Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q), change from baseline to end of treatment, Evaluation of vital signs, Incidence of Adverse Events (AEs) – PERT related | — |
Countries
Germany, Poland, Spain
Outcome results
None listed