drugset / Trial / NCT01813630

A Clinical Study to Assess the Efficacy and Safety of DA-3002

NCT01813630 ↗

Phase 3 Completed 58 enrolled Dong-A ST Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin®.

Timeline

Start
2013-02
Primary completion
2018-05
Completion
2018-05

Outcome

Met primary endpoint

paper The lower bound of 95% two-sided confidence interval for group difference in the change of annualized HV (- 1.02) satisfied the non-inferiority margin (- 1.5). PMID 34893062 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject DA-3002 Protein / enzyme biologic 0.14 iu/kg Other
Comparator Somatropin Protein / enzyme biologic 0.14 iu/kg Other

Indications