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

Recruiting

• Source

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  Public Title	Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis.
  Acronym	Sorry, not currently available
  Source of Record URL	http://clinicaltrials.gov/show/NCT01641393

• Trial

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  Health Condition(s) or Problem	Exocrine Pancreatic Insufficiency: Cystic Fibrosis
  Lay 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. (from ClinicalTrials.gov)
  Who can enter the trial	Inclusion Criteria: 1. Definitive diagnosis of CF based on the following: - One clinical feature consistent with CF and - Either a genotype with 2 identifiable mutations known to cause CF or a sweat chloride concentration >60 mEq/L by pilocarpine iontophoresis 2. Pancreatic insufficiency documented by a monoclonal faecal elastase (FE) 100 µg/g stool at screening (test results within the previous 12 months are acceptable) 3. Currently receiving pancreatic enzyme replacement therapy 4. Adequate nutritional status based on the following: body mass index (BMI) >19 kg/m2 in adult subjects or a BMI percentile 10th percentile for age in adolescent (12 to 17 years age group) subjects 5. Are clinically stable with no evidence of concomitant illness or acute upper or lower respiratory tract infection that requires antibiotics during the 7-day interval prior to screening and preceding entry into this clinical study Exclusion Criteria: 1. Age <12 years 2. Known contraindication, hypersensitivity, or intolerance to pork or other porcine PEPs 3. Current uncontrolled diabetes mellitus 4. History of solid organ transplantation 5. History of surgery affecting the bowel function and weight gain
  Who cannot enter the trial	Inclusion Criteria: 1. Definitive diagnosis of CF based on the following: - One clinical feature consistent with CF and - Either a genotype with 2 identifiable mutations known to cause CF or a sweat chloride concentration >60 mEq/L by pilocarpine iontophoresis 2. Pancreatic insufficiency documented by a monoclonal faecal elastase (FE) 100 µg/g stool at screening (test results within the previous 12 months are acceptable) 3. Currently receiving pancreatic enzyme replacement therapy 4. Adequate nutritional status based on the following: body mass index (BMI) >19 kg/m2 in adult subjects or a BMI percentile 10th percentile for age in adolescent (12 to 17 years age group) subjects 5. Are clinically stable with no evidence of concomitant illness or acute upper or lower respiratory tract infection that requires antibiotics during the 7-day interval prior to screening and preceding entry into this clinical study Exclusion Criteria: 1. Age <12 years 2. Known contraindication, hypersensitivity, or intolerance to pork or other porcine PEPs 3. Current uncontrolled diabetes mellitus 4. History of solid organ transplantation 5. History of surgery affecting the bowel function and weight gain
  What will happen	Drug; EUR-1008 25,000 Units; 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.; EUR-1008 then Kreon; Kreon then EUR-1008; Zenpep; Drug; Kreon 25,000 Units; 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.; EUR-1008 then Kreon; Kreon then EUR-1008; Kreon
  Primary aim	Coefficient of Fat Absorption over 72 hours (CFA-72h)
  Secondary Aim	Body weight; 58 days.; No; Body weight at baseline (Visit 2 [Day 0]) and at the end of each treatment period.; Coefficient of nitrogen absorption; 72 hours; No; 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; 2- 14 day periods; No; 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; 58 days; No; 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; 58 days; No; Total cholesterol, calculated LDL-C, HDL-C (sampling performed prior to randomisation and at the end of each treatment period).; Treatment Emergent Adverse Events; 78 days; Yes; Frequency, duration, and severity of treatment-emergent adverse events (TEAEs);; Standard safety laboratory tests; 58 days; Yes; 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; 78 days; Yes; Vital signs including blood pressure, heart rate, respirations and body temperature.; Fat-soluble vitamins A, D, and E; 58 days; No; Fat-soluble vitamins A, D, and E (sampling performed prior to randomisation and at the end of each treatment period).
  Participant Information Sheet	Sorry, not currently available
  Website	Sorry, not currently available
  Recruitment Status	Recruiting
  Nation	England
  Location	Liverpool, Sheffield

• Contact

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  Contact for Public Queries

  Christopher Taylor, MD, PhD Principal Investigator Sheffield Children's Hospital, The Academic Unit of Child Health

  Contact for Scientific Queries

  Kristine Desager, MD; Principal Investigator; Eddy Robberecht, MD; Principal Investigator; Vania Nedkova, MD; Principal Investigator; Miroslava Bosheva, MD; Principal Investigator; Svetoslav Dachev, MD; Principal Investigator; Ivan Galabov, MD; Principal Investigator; Raphael Chiron, MD; Principal Investigator; Vincent Rosner, MD; Principal Investigator; Manfred Ballmann, MD; Principal Investigator; Jutta Hammermann, MD; Principal Investigator; Uwe Mellies, MD; Principal Investigator; Urte Sommerwerck, MD; Principal Investigator; Jochen Mainz, MD; Principal Investigator; Rainald Fischer, MD; Principal Investigator; Joachim Riethmueller, MD; Principal Investigator; Rolando Gagliardini, MD; Principal Investigator; Antonio Manca, MD; Principal Investigator; Mario La Rosa, MD; Principal Investigator; Giuseppe Magazzu, MD; Principal Investigator; Valeria Raia, MD; Principal Investigator; Carlo Albera, MD; Principal Investigator; Giovanna Pisi, MD; Principal Investigator; Serenella Bertasi, MD; Principal Investigator; Vincenzina Lucidi, MD; Principal Investigator; Bruna Santini, MD; Principal Investigator; Marco Cipolli, MD; Principal Investigator; Maria Trawinska-Bartnicka, MD; Principal Investigator; Grzegorz Gaszczyk, MD; Principal Investigator; Iwona Stelmach, MD; Principal Investigator; Andrzej Emeryk, MD; Principal Investigator; Jaroslaw Walkowiak, MD; Principal Investigator; Henryk Mazurek, MD; Principal Investigator; Marta Rachel, MD; Principal Investigator; Marek Woynarowski, MD; Principal Investigator; Dorota Sands, MD; Principal Investigator; Martin Walshaw, MD; Principal Investigator; Christopher J Taylor, MD, PhD; Principal Investigator