Control of Steatorrhea in Patients With Cystic Fibrosis and Pancreatic Insufficiency

• Stool frequency [ Time Frame: 2 periods of 3 days each ] [ Designated as safety issue: No ]
• Stool consistency [ Time Frame: 2 periods of 3 days each ] [ Designated as safety issue: No ]
• Stool weight [ Time Frame: 2 periods of 3 days each ] [ Designated as safety issue: No ]
  Total stool weight and mean weight per stool sample will be assessed
• Frequency of subject's abdominal symptoms [ Time Frame: During both study treatments (28 to 34 days) ] [ Designated as safety issue: No ]
  Abdominal pain and excessive flatulence/gas production will be assessed as abdominal symptoms.
• Presence of abdominal distension [ Time Frame: Visits 1, 3 and 4 ] [ Designated as safety issue: No ]
• Role of acid suppression therapy on Coefficient of Fat Absorption [ Time Frame: 2 periods of 3 days each ] [ Designated as safety issue: No ]
  Each subject will be categorized as an ''acid suppression therapy user'' or a ''non-user''. For both sub-categories (use and no use of acid suppresion therapy), the CFA% measured with the two study drugs will be assessed to see if the use of acid suppresion therapy tends to affect or not the CFA%.
• Nutritional status of subjects [ Time Frame: Visits 1, 3 and 4 ] [ Designated as safety issue: Yes ]
  The nutritional status of subjects will be briefly described at Visit 1 (baseline) with parameters such as body weight and BMI, as well as blood levels of hemoglobin, hematocrit, transferrin, albumin, electrolytes, vitamins A, D and E. Except for vitamins A, D and E, the other blood level parameters will be compared to baseline at Visit 4 and weight and BMI will be compared to baseline at Visits 3 and 4.
• Number of adverse events reported by the subjects or found during physical examination or blood and urine tests [ Time Frame: From signature of ICF (Visit 1) to completion of the study (scheduled 7-10 days after Visit 4) or until discontinuation of the study ] [ Designated as safety issue: Yes ]
• Severity of subject's abdominal symptoms [ Time Frame: During both study treatments (28 to 34 days) ] [ Designated as safety issue: No ]
  The severity of abdominal symptoms reported by the subject, respectively abdominal pain and excessive flatulence/gas production will be assessed.
• Nature of adverse events reported by the subjects or found during physical examination or blood and urine tests [ Time Frame: From signature of ICF (Visit 1) to completion of the study (scheduled 7-10 days after Visit 4) or until discontinuation of the study ] [ Designated as safety issue: Yes ]

The purpose of this study is to assess the efficacy of Panzytrat™ 25 000 compared to Kreon 25 000 in the control of steatorrhea in cystic fibrosis subjects with exocrine pancreatic insufficiency.

• Exocrine Pancreatic Insufficiency
• Cystic Fibrosis

• Drug: Pancreatin
  Capsule with gastro-resistant microtablets containing 25,000 Ph. Eur. unit of lipase,at least 15,000 Ph. Eur. unit of amylase and at least 800 Ph. Eur. unit of protease
  Other Names:

  • Pancreatic enzyme supplement
  • Pancreatic enzyme products
  • Pancreatic enzyme replacement therapy
• Drug: Pancreatin
  Capsule with enteric coated pellets containing 25,000 Ph. Eur. unit of lipase,at least 18,000 Ph. Eur. unit of amylase and at least 1000 Ph. Eur. unit of protease
  Other Names:

  • Pancreatic enzyme supplement
  • Pancreatic enzyme products
  • Pancreatic enzyme replacement therapy

• Experimental: Panzytrat™ 25000
  Intervention: Drug: Pancreatin
• Active Comparator: Kreon 25000
  Interventions:

  • Drug: Pancreatin
  • Drug: Pancreatin

Inclusion Criteria:

• Signed informed consent form by the subject
• Clinical diagnosis of cystic fibrosis
• Severe Pancreatic insufficiency confirmed by Fecal Elastase-1 (ELISA)
• Male or female subject aged 7 years or older
• Current treatment with stable dose of Panzytrat™ 25 000 or Kreon 25 000
• Women of childbearing potential have a negative pregnancy test at study entry and must use a medically acceptable contraceptive method for the duration of the study

Exclusion Criteria:

• Known hypersensitivity to Panzytrat™ or Kreon, or to any porcine protein
• Recent treatment with oral or intravenous antibiotics, not completed at least 14 days prior to randomization
• History of significant bowel resection that could impair fat absorption
• Presence of any condition known to increase fecal fat loss
• Presence of any significant gastrointestinal dysmotility disorders
• Subject with chronic abdominal pain or severe abdominal pain at study entry
• Use of enteral tube feeding over day and night
• History or presence of clinically significant portal hypertension
• Complete Distal Intestinal Obstruction Syndrome (DIOS) in the past six (6) months, or two (2) or more episodes of DIOS in the past year
• Subject with poorly controlled diabetes as per the investigator's opinion