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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
EUR-1008 25,000 Units is a PEP with pancreas powder as the active ingredient.18 Pancreas powder contains various enzymes having proteolytic, lipolytic, and amylolytic activity. Each capsule contains approximately 25,000 Ph. Eur. lipase units. EUR-1008 25,000 consists of orally administered capsules containing enteric-coated beads.
Kreon 25,000 is a PEP consisting of porcine-derived pancreatic enzymes.18 Each capsule contains approximately 25,000 Ph. Eur. lipase units. Kreon 25,000 consists of orally administered capsules containing enteric-coated spheres.
Coefficient of Fat Absorption over 72 hours (CFA-72h)
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.
Time frame: 72 hours
Body weight
Body weight at baseline (Visit 2 \[Day 0\]) and at the end of each treatment period.
Time frame: 58 days.
Coefficient of nitrogen absorption
Coefficient of nitrogen absorption at the end of each treatment period as assessed by a specialised central laboratory by means of Dumas combustion method.
Time frame: 72 hours
Control of signs and symptoms of EPI
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)
Time frame: 2- 14 day periods
Impact on overall health, daily life, perceived well-being, and symptoms
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).
Time frame: 58 days
Total cholesterol, calculated LDL-C, HDL-C
Total cholesterol, calculated LDL-C, HDL-C (sampling performed prior to randomisation and at the end of each treatment period).
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University Hospital Antwerp - Universitair Ziekenhuis Antwerpen (UZA)
Antwerp, Belgium
Universitair Ziekenhuis Gent, Centrum voor Mucoviscidose
Ghent, Belgium
Clinic of Paediatric Diseases at UMHAT Dr Georgi Stranski
Pleven, Bulgaria
Clinic of Genetic and Paediatric Diseases at UMHAT Sveti Georgi
Plovdiv, Bulgaria
Specialized Hospital for Active Treatment of Pulmological and Phtisiatric Disease
Rousse, Bulgaria
Multiprofile Clinic for Specialized Pediatric Clinic at MHAT Sveta Marina
Varna, Bulgaria
Hôpital Arnaud de Villeneuve
Montpellier, France
Nouvel Hôpital Civil
Strasbourg, France
Ruhr-Universitaet Bochum - St. Josef Hospital
Bochum, Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Germany
...and 27 more locations
Time frame: 58 days
Treatment Emergent Adverse Events
Frequency, duration, and severity of treatment-emergent adverse events (TEAEs);
Time frame: 78 days
Standard safety laboratory tests
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
Time frame: 58 days
Vital signs
Vital signs including blood pressure, heart rate, respirations and body temperature.
Time frame: 78 days
Fat-soluble vitamins A, D, and E
Fat-soluble vitamins A, D, and E (sampling performed prior to randomisation and at the end of each treatment period).
Time frame: 58 days