Overview

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

Status:
Unknown status

Trial end date:
2017-09-01

Target enrollment:

Participant gender:

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).

Phase:

Phase 4

Details

Lead Sponsor:

Duchesnay Inc.

Collaborator:

Premier Research Group plc

Treatments:

Dicyclomine
Dicyclomine, doxylamine, pyridoxine drug combination
Doxylamine
Pyridoxine