Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
Condition: Exocrine Pancreatic Insufficiency; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Steatorrhea; Fibrosis
Intervention: Panzytrat® 25,000; Kreon® 25,000
Intervention description: Panzytrat® 25,000 capsule will be given orally daily at a stabilized dose, as per investigator's discretion, for 14 days. Stabilized dose for a participant will be the optimal dose determined during a qualification phase that precedes the first treatment period and will be based upon the participant's usual lipase and lipid intake. Total dose will not exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day in either first treatment period or second treatment period.; Kreon® 25,000 capsule will be given orally daily at a stabilized dose, as per investigator's discretion, for 14 days. Stabilized dose for a participant will be the optimal dose determined during a qualification phase that precedes the first treatment period and will be based upon the participant's usual lipase and lipid intake. Total dose will not exceed 10,000 Ph.Eur. units lipase/kg body weight/day in either first treatment period or second treatment period.
Intervention MeSH terms: Pancreatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 7 Years
Healthy volunteers: No
Keywords: Exocrine Pancreatic Insufficiency; Cystic Fibrosis; Steatorrhea; Malabsorption; Malnutrition

Summary:

      This study by Aptalis (formerly Axcan) assesses the efficacy and safety of Panzytrat® 25,000
      compared to Kreon® 25,000 in the control of steatorrhea in participants with cystic fibrosis
      (CF) and exocrine pancreatic insufficiency (EPI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant or his/her legal representative signed informed consent form (ICF) prior
             to starting any study procedures

          -  Participant with clinical diagnosis of CF based on one or more typical clinical
             features of CF phenotype, in addition to one of the following: a genotype that
             documents the presence of 2 CF-causing mutation, or a sweat chloride test greater than
             or equal to 60 millimole per liter (mmol/L) by quantitative pilocarpine iontophoresis
             on 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 either
             Panzytrat® 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 associated
             with CF and EPI, and is clinically stable (no change in the last 30 days of physical
             examination) as evidenced by medical and medication histories, physical examination
             including vital signs during screening and laboratory tests

          -  Participant able to maintain a CF standardized diet with a lipid content customized to
             his/her needs during the study according to the qualification phase diary

          -  Women of childbearing potential must have a negative pregnancy test at study entry and
             must 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 oral
             or intravenous (IV) antibiotics that was not stopped at least 14 days prior to
             randomization

          -  Participant with chronic use of narcotics that were not stopped at least 7 days prior
             to the qualification visit

          -  Participant using of any prohibited medications or products listed in the prohibited
             medication section of the protocol

          -  Participant with acute pancreatitis or exacerbation of chronic pancreatic disease

          -  Participant with history of significant bowel resection that could impair fat
             absorption

          -  Participant with any condition known to increase fecal fat loss including but not
             limited to: celiac disease, Crohn's disease, tropical sprue, bacterial bowel
             infection, liver disease, lactose intolerance, pseudomembranous colitis, biliary and
             pancreatic 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 obstruction
             syndrome (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 laboratory
             abnormality which, in the opinion of the investigator or sponsor, might put the
             participant at risk, prevent the participant from completing the study, or otherwise
             affect the outcome of the study

          -  Participant using any investigational drug within 30 days prior to the date of
             signature of the ICF