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

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

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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