drugset / Trial / NCT00401076
A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine Insufficiency
NaSingle-groupOpen-labelTreatment
Summary
This study is to evaluate the safety of 3.0 g/day of SA-001 (to be flexibly increased or decreased with the range from 1.5 g/day to 6.0 g/day), which will orally be administered for 52 weeks to patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by pancreatectomy.
Timeline
- Start
- 2008-07
- Primary completion
- 2010-09
- Completion
- 2010-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pancrelipase | Protein / enzyme biologic | 3 g | Oral |