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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
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.
Details
| Lead sponsor | Forest Laboratories |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 96 |
| Start date | 2012-06 |
| Completion | 2014-02 |
Conditions
- Exocrine Pancreatic Insufficiency: Cystic Fibrosis
Interventions
- EUR-1008 25,000 Units
- Kreon 25,000 Units
Primary outcomes
- Coefficient of Fat Absorption over 72 hours (CFA-72h) — 72 hours
During the last 72 hours of each treatment period, the CFA-72h will be calculated using fat intake data from the diet and fat excretion data from stools. Fat intake will be calculated by the dietician in collaboration with the study investigator using a validated tool.
Countries
Belgium, Bulgaria, France, Germany, Italy, Poland, United Kingdom