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

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Forest Laboratories

Status and phase

Completed
Phase 3

Conditions

Exocrine Pancreatic Insufficiency: Cystic Fibrosis

Treatments

Drug: EUR-1008 25,000 Units
Drug: Kreon 25,000 Units

Study type

Interventional

Funder types

Industry

Identifiers

NCT01641393
2009-012842-21 (EudraCT Number)
PR-005

Details and patient eligibility

About

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.

Enrollment

96 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
  • Pancreatic insufficiency documented by a monoclonal faecal elastase (FE) 100 μg/g stool at screening (test results within the previous 12 months are acceptable)
  • Currently receiving pancreatic enzyme replacement therapy
  • 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
  • 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

  • Age <12 years
  • Known contraindication, hypersensitivity, or intolerance to pork or other porcine PEPs
  • Current uncontrolled diabetes mellitus
  • History of solid organ transplantation
  • History of surgery affecting the bowel function and weight gain

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

96 participants in 2 patient groups

EUR-1008 then Kreon
Experimental group
Description:
EUR-1008 during Treatment Period 1 (29 days ±2 days) and Kreon during Treatment Period 2 (29 days ±2 days).
Treatment:
Drug: Kreon 25,000 Units
Drug: EUR-1008 25,000 Units
Kreon then EUR-1008
Experimental group
Description:
Kreon during Treatment Period 1 (29 days ±2 days) and EUR-1008 during Treatment Period 2 (29 days ±2 days).
Treatment:
Drug: Kreon 25,000 Units
Drug: EUR-1008 25,000 Units

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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