drugset / Trial / NCT02045901

A Multicenter Trial of the Efficacy and Safety of Diclegis® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents

NCT02045901 ↗

Phase 4 Terminated 131 enrolled Duchesnay Inc. Premier Research · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to compare the efficacy of Diclegis for the treatment of nausea and vomiting of pregnancy (NVP) in pregnant adolescents aged 12 to 17 years with placebo. The secondary objective of this study is to compare the safety of Diclegis in pregnant adolescents aged 12 to 17 years with placebo by assessing differences in the severity and occurrence of maternal adverse events (AEs).

Timeline

Start
2014-02
Primary completion
2017-03-31
Completion
2017-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Diclegis Unknown — —

Indications

No indication recorded.