Randomized Double-Blind Placebo Crossover Study to Evaluate Safety/Efficacy of Two Doses in CP Patients With EPI

Inclusion Criteria:

• Male or female
• Age over 18
• Written, legally valid informed consent
• Women of childbearing potential must be using a medically acceptable form of birth control for the 30 days prior to the beginning of the study and agree to maintain adequate birth control measures during the whole duration of the study plus an additional 30 days as well as have a negative pregnancy test at screening Visit 3 and Visit 7.
• Documented diagnosis of CP by medical history and it is preferred that it is supported by imaging evidence confirming CP which include: Abnormal ERCP [Endoscopic Retrograde Cholangio-Pancreatography] (Cambridge Class 4), Abnormal CT scan (dilated main pancreatic duct, atrophy of the pancreas or calcification) Abnormal Ultrasound, or Endoscopic Ultrasound with at least 5 abnormalities noted (V. Gupta and P.P. Toskes "Diagnosis and Management of Chronic Pancreatitis" Postgrad.Med.J: 2005; 81; 491-497)
• In the case of pancreatic surgery, the patient can be included with partial or distal resection of the pancreas (not due to cancer)
• Documented EPI with target Fecal Elastase ≤ 100 mcg/g of stool using the monoclonal test (Pancreatic Elastase 1 (PE1) by Genova Diagnostics) performed at the screening visit. The mean CV for the FE test is 20%.

Exclusion Criteria:

• Patients known to the Investigator to have a significant medical and/or mental disease that would compromise the patient's welfare, pose an unacceptable risk to him/her or confound the study results
• Participation in a clinical trial within 30 days of randomization or per specific country regulations/guidelines.
• Cystic fibrosis
• Excessive alcohol consumption
• Drug abuse
• Contraindicated or unable to discontinue prohibited concomitant medication, (see Section 5.2)

• Uncontrolled diabetes mellitus that, according to the publication on Diabetes Care 25:S109, 2002 by the American Diabetes Association Inc., defines poor metabolic control of established diabetes, as follows:

  • Hyperglycemia associated with volume depletion.
  • Persistent refractory hyperglycemia associated with metabolic deterioration.
  • Recurring fasting hyperglycemia >300 mg/dl (>16.7 mmol/l) that is refractory to outpatient therapy or an A1C level 100% above the upper limit of normal.
  • Recurring episodes of severe hypoglycemia (i.e., <50 mg/dl [<2.8 mmol/l]) despite intervention.
  • Metabolic instability manifested by frequent swings between hypoglycemia (<50 mg/dl [<2.8 mmol/l]) and fasting hyperglycemia (>300 mg/dl [>16.7 mmol/l]).
  • Recurring diabetic ketoacidosis without precipitating infection or trauma.
  • Repeated absence from school or work due to severe psychosocial problems causing poor metabolic control that cannot be managed on an outpatient basis.
• Allergy to pork protein/ unwilling to ingest pork products
• Atopic predisposition such as multiple drug hypersensitivity, allergic asthma, urticaria, or other relevant allergic diathesis
• Pregnancy or lactation
• Acute pancreatitis or acute exacerbation in chronic pancreatitis
• Acute biliary disease
• Malabsorption syndrome caused by a metabolic disease or by surgery, not related to exocrine pancreatic insufficiency
• Any resection of the stomach or the gastrointestinal tract that will affect transit time and/or gastric emptying.
• Evidence of active gastric or duodenal ulcer
• Chronic inflammatory bowel disease
• Any history of pancreatic cancer and other non- cutaneous malignancies (except basal cell and squamous cell carcinoma of the skin in situ that have been removed and not reoccurred in 5 years)
• Viral hepatitis with infectious virions in blood and/or body fluids (any etiology)
• HIV infection
• Hyperuricemia ( > 1.5 times Upper Normal Value for lab)
• Any acute or chronic disease, which in the opinion of the investigator could influence study results or pose a risk to the patient's safety.