Pancreatic exocrine insufficiency after acute pancreatitis. Insuficiencia pancreática exocrina tras un episodio de pancreatitis aguda. MedDRA version: 9.1 Level: LLT Classification code 10033628 Term: Pancreatic insufficiency
Conditions
Interventions
Trade Name: Creon forte
Pharmaceutical Form: Capsule*
INN or Proposed INN: Pancreas Powder
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300.00-
Pharmaceutical fo
Sponsors
Solvay Pharmaceutical GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent 2. Subject must be ? 18 years of age 3. Acute pancreatitis has to be proven (in medical history of this current acute pancreatitis) by CT, ultrasonography or other suitable imaging technique showing pancreatic changes due to AP 4. Acute pancreatitis has to be characterized by serum enzymes: serum pancreatic amylase, serum pancreatic lipase > 3-fold than normal and CRP > 150mg/L, (in medical history of this current acute pancreatitis, measured in the first 2-3 days of the current attack) 5. Severity score of acute pancreatitis has to be APACHE II score ? 8 at admission to the hospital 6. Pancreatic exocrine insufficiency proven after this current acute pancreatitis using Elastase 1 in stool =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic (except underlying disease), hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/ connective tissue, musculoskeletal, metabolic/nutritional (except underlying disease), endocrine (except diabetes mellitus), neurologic / psychiatric, allergy, recent major surgery, or other relevant diseases as revealed by history, physical examination and/or laboratory assessments which, might limit participation in or completion of the study. 2. Known pancreatic exocrine insufficiency due to e.g. chronic pancreatitis or partial or total pancreatectomy 3. Investigational drug intake within 30 days prior to the study entry 4. Known allergy to pancreatin or inactive ingredients of Creon® 5. Ileus or acute abdomen 6. Any type of malignancy involving the digestive tract in the last 5 years 7. Presence of symptomatic pancreatic pseudocyst or pseudocysts that are likely to cause complications 8. Patient?s inability to tolerate study procedures and/or pursue the 1 year clinical phase 9. Current excessive intake of alcohol or drug abuse 10. Celiac disease, gastrectomy, Crohn?s disease and small bowel surgery 11. Suspected non-compliance or non-cooperation 12. Mental disability or any other lack of fitness, in the investigator?s opinion, to preclude subject?s participation in or to complete the study. 13. Known infection with HIV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superior efficacy of Creon® 25.000 MinimicrospheresTM (Creon 25.000 MMS) over placebo in improving fat digestion in subjects suffering from PEI after an attack of acute pancreatitis. The primary efficacy parameter will be the change in the coefficient of fat absorption (CFA) from baseline to the end of double-blind treatment.;Secondary Objective: To investigate the short- and long-term effect of Creon® 25.000 MMS on CFA, the coefficient of nitrogen absorption (CNA), stool fat, stool weight, BMI, nutritional parameters (triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol, retinol-binding protein, transferrin, total protein, albumin, prealbumin, vitamin E), clinical symptomatology (abdominal pain, stool frequency and consistency, flatulence), and Quality of life (QoL) (SF-36).;Primary end point(s): The primary objective of the study is to demonstrate superior efficacy of Creon® 25.000 MMS over placebo in improving fat digestion in subjects after an attack of acute pancreatitis suffering from PEI. The primary efficacy variable will be the change in CFA from baseline to the end of double-blind treatment. | — |
Countries
Spain
Outcome results
None listed