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.Estudio multicéntrico, aleatorizado, doble ciego, controlado conplacebo, de grupos paralelos y de tres meses de duración conCreon® 25.000 MMS? en sujetos afectados por una insuficiencia pancreática exocrina tras un episodio de pancreatitis aguda, seguido de una extensión a largo plazo en régimen abierto de nueve meses.

Conditions: Pancreatic exocrine insufficiency after acute pancreatitis.Insuficiencia pancreática exocrina tras un episodio de pancreatitis aguda.
MedDRA version: 9.1Level: LLTClassification code 10033628Term: Pancreatic insufficiency

Registration Number: EUCTR2008-005993-12-ES

Lead Sponsor: Solvay Pharmaceutical GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 124

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 of childbearing potential, agree to practice effective barrier contraceptive methods, use an intrauterine device (IUD) or use birth control pills or equivalent injectable contraceptive. The subject must have been practicing the selected method of birth control for at least 3 months prior to Visit 1 (Day -14)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.