Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Inclusion Criteria

• •1. Subject has voluntarily signed and dated the Informed Consent Form (ICF). For subjects aged less than 18 years, the parents, or a legally acceptable representative, must sign consent and, as required by the Independent Ethics Committee (IEC), assent will be given by the subject.
• •2. Subject is 12 years old or older at the time of consent signature.
• •3. Subject has a diagnosis of CF previously confirmed by:
• •* a sweat chloride test \> or equal to 60 mmol/Ls and/or
• •* two CF causing Cystic Fibrosis trans membrane conductance regulator (CFTR) mutations and
• •* CF clinical features
• •4. Subject has a documented clinically confirmed diagnosis of pancreatic exocrine insufficiency.
• •5. Subject has human fecal elastase \< 100 µg/g stool at screening
• •6. Subject has PEI that is currently clinically controlled (no clinically overt steatorrhea or diarrhea) under treatment with a commercially available Pancreatic enzyme Replacement Therapy (PERT), on an individually established dose regimen for more than 3 months, with a daily dose not exceeding 10,000 U lipase/kg/day.
• •7. Females of child-bearing potential and sexually active with men should agree to continue using a medically acceptable method of birth control throughout the study and for 7 days immediately after the last dose of study drug. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection (e.g., Depo Provera™), an intrauterine device, or an oral contraceptive taken continually within the past three months and which the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide.