drugset / Trial / NCT00400842
A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is to verify the efficacy of 3.0 g/day of SA-001 in patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by pancreatectomy as compared with placebo under a double-blind design using the change in a coefficient of fat absorption as a primary endpoint.
Timeline
- Start
- 2007-05
- Primary completion
- 2009-08
- Completion
- 2009-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pancrelipase | Protein / enzyme biologic | 1.5 g | Oral |
| Subject | Pancrelipase | Protein / enzyme biologic | 3 g | Oral |