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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

  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

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

37

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Data sourced from clinicaltrials.gov

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