Male and female patients aged ≥ 18 to ≤ 80 after total gastrectomy.
Conditions
Brief summary
Proportion of patients on stable dose of Creon, in whom there is no deterioration of nutritional status (as measured by no loss of body weight from baseline Visit).
Detailed description
Change in bodyweight from baseline, Percentage of patients who develop symptomatic pancreatic exocrine insufficiency after gastrectomy., Symptoms of pancreatic exocrine insufficiency measured (as recorded in subject diaries), Nutritional parameters, Gastrointestinal Quality of life index (GIQLI) questionnaire, Treatment Emergent Adverse Events (TEAEs), Change in vital signs
Interventions
DRUGCreon® 25000 Capsules
Sponsors
BGP Products Operations GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients on stable dose of Creon, in whom there is no deterioration of nutritional status (as measured by no loss of body weight from baseline Visit). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in bodyweight from baseline, Percentage of patients who develop symptomatic pancreatic exocrine insufficiency after gastrectomy., Symptoms of pancreatic exocrine insufficiency measured (as recorded in subject diaries), Nutritional parameters, Gastrointestinal Quality of life index (GIQLI) questionnaire, Treatment Emergent Adverse Events (TEAEs), Change in vital signs | — |
Countries
Poland, Portugal, Spain
Outcome results
None listed