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EUR-1008 vs Kreon for EPI in Cystic Fibrosis
NCT01641393Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2012
- Primary completion
- Feb 2014
- Countries
- 7
- Sponsor
- Forest Laboratories
- Modality
- Replacement Enzymes
- Drugs
- pancreatin
- Conditions
- exocrine pancreatic insufficiency (EPI)
01
Overview
Phase 3, randomised, double-blind trial of pancreatin in exocrine pancreatic insufficiency (EPI) (2 arms), sponsored by Forest Laboratories. Primary endpoint: Coefficient of Fat Absorption over 72 hours. Started Jun 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
EUR-1008 then Kreon
EUR-1008 in Period 1, Kreon in Period 2
Kreon then EUR-1008
Kreon in Period 1, EUR-1008 in Period 2
03
Who it enrols
Patients 12+ with Cystic Fibrosis and documented Exocrine Pancreatic Insufficiency (fecal elastase <100 μg/g), currently on PERT, with adequate nutritional status.
04
Endpoints
Primary
Coefficient of Fat Absorption over 72 hours
Secondary
Body weight
Coefficient of nitrogen absorption
Control of signs and symptoms of EPI
Impact on overall health, daily life, perceived well-being, and symptoms
Total cholesterol, calculated LDL-C, HDL-C
Treatment Emergent Adverse Events
Fat-soluble vitamins A, D, and E
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