drugset / Trial / NCT00658905

Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants

NCT00658905 ↗

Phase 2 Completed 33 enrolled Swedish Orphan Biovitrum
RandomizedCrossoverQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula.

Timeline

Start
2008-04
Primary completion
2009-05
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator rhBSSL Protein / enzyme biologic 0.15 mg/ml —

Indications

No indication recorded.