drugset / Trial / NCT01327703
Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
RandomizedCrossoverOpen-labelTreatment
Summary
This study by Aptalis (formerly Axcan) assesses the efficacy and safety of Panzytrat® 25,000 compared to Kreon® 25,000 in the control of steatorrhea in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).
Timeline
- Start
- 2011-04
- Primary completion
- 2012-05
- Completion
- 2012-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Kreon | Protein / enzyme biologic | 10000 iu/kg | Oral |
| Subject | Panzytrat | Protein / enzyme biologic | 10000 iu/kg | Oral |