A three month double-blind, randomized, placebo-controlled, parallel group, multi-center study with Creon® 25.000 MMS? in subjects after an attack of acute pancreatitis suffering from pancreatic exocrine insufficiency, followed by an open-label long-term extension of nine months.

INTERVENTION: 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 form of the placebo: Capsule* Route of administration of the placebo: Oral use CONDITION: 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 PRIMARY OUTCOME: 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. 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. 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). 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 < 100 mcg/g in three daily consecutive measurements 7. Females must be non‐lactating and either be of non‐childbearing potential (ie, sterilized via hysterectomy or bilateral tubal ligation or at least 1 year postmenopausal) or if o