Clinical Trial: Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in the Treatment of Exocrine P

Brief Summary: The purpose of the study is to further evaluate the safety and efficacy of EUR-1008 as compared to Kreon® in the treatment of exocrine pancreatic insufficiency associated with Cystic Fibrosis in subjects 12 years of age and older.

Detailed Summary:
Sponsor: Forest Laboratories

Current Primary Outcome: Coefficient of Fat Absorption over 72 hours (CFA-72h) [ Time Frame: 72 hours ]

During the last 72 hours of each treatment period, the CFA-72h will be calculated using fat intake data from the diet and fat excretion data from stools. Fat intake will be calculated by the dietician in collaboration with the study investigator using a validated tool.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Body weight [ Time Frame: 58 days. ]
    Body weight at baseline (Visit 2 [Day 0]) and at the end of each treatment period.
  • Coefficient of nitrogen absorption [ Time Frame: 72 hours ]
    Coefficient of nitrogen absorption at the end of each treatment period as assessed by a specialised central laboratory by means of Dumas combustion method.
  • Control of signs and symptoms of EPI [ Time Frame: 2- 14 day periods ]

    Control of signs and symptoms of EPI (as recorded in subject diaries). The following will be captured:

    • Stools frequency (number/day)
    • Stools consistency (hard, formed/normal; soft, watery, overt diarrhoea)
    • Fat or grease visible in stools (Yes/No)
    • Abdominal pain (mild, moderate, severe)
    • Bloating (mild, moderate, severe)
    • Flatulence (mild, moderate, severe)
  • Impact on overall health, daily life, perceived well-being, and symptoms [ Time Frame: 58 days ]
    Impact on overall health, daily life, perceived well-being, and symptoms evaluated using the CFQ (administered by designated study personnel prior to randomisation and at the end of each treatment period).
  • Total cholesterol, calculated LDL-C, HDL-C [ Time Frame: 58 days ]
    Total cholesterol, calculated LDL-C, HDL-C (sampling performed prior to randomisation and at the end of each treatment period).
  • Treatment Emergent Adverse Events [ Time Frame: 78 days ]
    Frequency, duration, and severity of treatment-emergent adverse events (TEAEs);
  • Standard safety laboratory tests [ Time Frame: 58 days ]

    Standard safety laboratory tests, analysed by central laboratory:

    • Haematology: red blood cell count, haemoglobin, haematocrit, total leukocytes with diff count, and platelets
    • Serum biochemistry: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total protein, albumin, total bilirubin, direct and indirect bilirubin, blood urea nitrogen, uric acid, creatinine, fasting plasma glucose, fasting cholesterol evaluations (total cholesterol, LDL-C, HDL-C, and triglycerides), fat-soluble vitamins (A, D, and E) and serum electrolytes
  • Vital signs [ Time Frame: 78 days ]
    Vital signs including blood pressure, heart rate, respirations and body temperature.
  • Fat-soluble vitamins A, D, and E [ Time Frame: 58 days ]
    Fat-soluble vitamins A, D, and E (sampling performed prior to randomisation and at the end of each treatment period).


Original Secondary Outcome: Same as current

Information By: Forest Laboratories

Dates:
Date Received: July 10, 2012
Date Started: June 2012
Date Completion:
Last Updated: March 13, 2014
Last Verified: March 2014