drugset / Trial / NCT00880100
Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF)
NaSingle-groupOpen-labelTreatment
Summary
Multicenter, explorative, phase IIIb, open-label study to assess the efficacy and safety of Ultrase® MT12, in the control of steatorrhea and clinical signs and symptoms of malabsorption in CF children with pancreatic insufficiency (PI). This study is sponsored by Aptalis Pharma (formerly Axcan).
Timeline
- Start
- 2009-04
- Primary completion
- 2009-11
- Completion
- 2009-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ultrase® MT12 | Unknown | 2500 iu/kg | Oral |
| Subject | Ultrase® MT12 | Unknown | 10000 iu/kg | Oral |