Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis. | Completed
Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis.
Health Conditions
  • Exocrine Pancreatic Insufficiency: Cystic Fibrosis
Completed
Recruitment Status
NCT01641393
Primary Trial ID Number
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.
Primary Outcome Measures
  • Coefficient of Fat Absorption over 72 hours (CFA-72h); 72 hours
Secondary Outcome Measures
  • Body weight; 58 days.; Coefficient of nitrogen absorption; 72 hours; Control of signs and symptoms of EPI; 2- 14 day periods; Impact on overall health, daily life, perceived well-being, and symptoms; 58 days; Total cholesterol, calculated LDL-C, HDL-C; 58 days; Treatment Emergent Adverse Events; 78 days; Standard safety laboratory tests; 58 days; Vital signs; 78 days; Fat-soluble vitamins A, D, and E; 58 days
Research Question
  • 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.
Design Type
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Ethics Approval
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Publications
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Countries of Recruitment
Belgium; Bulgaria; France; Germany; Italy; Poland; United Kingdom
Participant Sex
Both
Participant Age Range
12 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
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Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
  • 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
Interventions
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]; 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]
Design Details
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Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific Title
A Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in the Treatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis
Secondary Trial Identifying Number
2009-012842-21
Website
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Study Funded By
Forest Laboratories
Funder Type
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Study Sponsored By
Forest Laboratories
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

10 Jul 2012

Last Updated

13 Mar 2014

Date Record Refreshed on UKCTG

31 Jul 2015