Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency

Inclusion Criteria:

• Participant or his/her legal representative signed informed consent form (ICF) priorto starting any study procedures

• Participant with clinical diagnosis of CF based on one or more typical clinicalfeatures of CF phenotype, in addition to one of the following: a genotype thatdocuments the presence of 2 CF-causing mutation, or a sweat chloride test greater thanor equal to 60 millimole per liter (mmol/L) by quantitative pilocarpine iontophoresison two separate occasions

• Participant with severe EPI confirmed by enzyme-linked immunosorbent assay (ELISA)measurement of fecal elastase-1 (FE-1)

• Male or female participant aged 7 years or older

• Participant currently receiving and has received a stable dose of lipase with eitherPanzytrat® 25,000 or Kreon® 25,000 for at least 30 days prior to ICF signature

• Participant generally in good health, except for the underlying symptoms associatedwith CF and EPI, and is clinically stable (no change in the last 30 days of physicalexamination) as evidenced by medical and medication histories, physical examinationincluding vital signs during screening and laboratory tests

• Participant able to maintain a CF standardized diet with a lipid content customized tohis/her needs during the study according to the qualification phase diary

• Women of childbearing potential must have a negative pregnancy test at study entry andmust use a medically acceptable contraceptive method for the duration of the study

Exclusion Criteria:

• Participant with known contraindication, sensitivity or hypersensitivity to Panzytrat® 25,000 or Kreon® 25,000, or to any porcine protein

• Participant who recently received treatment of an emergent acute infection with oralor intravenous (IV) antibiotics that was not stopped at least 14 days prior torandomization

• Participant with chronic use of narcotics that were not stopped at least 7 days priorto the qualification visit

• Participant using of any prohibited medications or products listed in the prohibitedmedication section of the protocol

• Participant with acute pancreatitis or exacerbation of chronic pancreatic disease

• Participant with history of significant bowel resection that could impair fatabsorption

• Participant with any condition known to increase fecal fat loss including but notlimited to: celiac disease, Crohn's disease, tropical sprue, bacterial bowelinfection, liver disease, lactose intolerance, pseudomembranous colitis, biliary andpancreatic cancer, radiation enteritis, Whipple's disease, Whipple's procedure, etc

• Participant with any significant gastrointestinal dysmotility disorders

• Participant with chronic abdominal pain or severe abdominal pain at study entry

• Participant using enteral tube feeding over day and night

• Participant with history or presence of clinically significant portal hypertension

• Participant with history or presence of complete distal intestinal obstructionsyndrome (DIOS) in the past 6 months, or 2 or more episodes of DIOS in the past year

• Participant with poorly controlled diabetes as per the investigator's opinion

• Female participants who are pregnant or breastfeeding

• Participant with any condition or history of any illness, or pre-study laboratoryabnormality which, in the opinion of the investigator or sponsor, might put theparticipant at risk, prevent the participant from completing the study, or otherwiseaffect the outcome of the study

• Participant using any investigational drug within 30 days prior to the date ofsignature of the ICF