drugset / Trial / NCT03159104

Efficacy and Safety of Tenoten for Children in the Treatment of Specific Developmental Disorders of Scholastic Skills in Children

NCT03159104 ↗

Phase 3 Completed 240 enrolled Materia Medica Holding
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Purpose of the study: • To evaluate efficacy and safety of Tenoten for children in the treatment of specific developmental disorders of scholastic skills in children.

Timeline

Start
2015-08-25
Primary completion
2019-02-18
Completion
2019-02-18

Outcome

Met primary endpoint

registry analysis (superiority test); Tenoten for Children vs Placebo; p = 0.0113; Median Difference (Final Values) 5 (95% CI 1 to 9); Wilcoxon (Mann-Whitney) NCT03159104 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenoten for children Unknown 1 unknown Oral