drugset / Trial / NCT02137382
A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
RandomizedCrossoverQuadruple-blindTreatment
Summary
maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis
Timeline
- Start
- 2014-01
- Primary completion
- 2014-08
- Completion
- 2014-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Creon N | Unknown | 8000 iu/kg | — |
| Subject | Creon N | Unknown | 10000 iu/kg | — |
| Subject | Pancrelipase | Protein / enzyme biologic | 8000 iu/kg | — |
| Subject | Pancrelipase | Protein / enzyme biologic | 10000 iu/kg | — |