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Study Of Effectiveness Of The Use Of Pancreatic Enzyme: Norzyme® -(Made In The Laboratory Pancrealipase Bergamo) Inpatients With Pancreatic Insufficiency In Use Substituteenzymatic When Compared To Product Creon®
Prove the efficacy of pancreatic enzyme Norzyme ® imported by Pharmaceutical Chemistry Laboratory Bergamo Ltda. verified by activity lipase contained in the formulation in controlling steatorrhea in 16 patients of both sexes aged 14 to 65 years, patients with pancreatic insufficiency Exogenous any cause. It's effectiveness will be found in a study randomized, crossover, comparative biosimilar product produced by Creon ® Laboratory Solvay Farma Ltda.
Details
| Lead sponsor | Azidus Brasil |
|---|---|
| Phase | Phase 3 |
| Status | WITHDRAWN |
| Start date | 2007-06 |
| Completion | 2011-12 |
Conditions
- Chronic Renal Failure
Interventions
- Pancreatic enzimes
- Creon ®
Primary outcomes
- Balance of fat in feces. — 06 weeks of treatment.
Countries
Brazil