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

PHASE4TerminatedINTERVENTIONAL
Enrollment

131

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

March 31, 2017

Study Completion Date

October 31, 2017

Conditions
Morning Sickness
Interventions
DRUG

Diclegis

On Day 1, all participants will take 2 tablets of Diclegis at bedtime. On Days 2 to 14, participants will take 2 tablets of Diclegis at bedtime. The minimum dosage will be 2 tablets daily at bedtime, increasing, when indicated, to the maximal dosage of 4 tablets per day on Days 3 to 14.

DRUG

Placebo (Sugar Pill)

On Day 1, all participants will take 2 tablets of Placebo at bedtime. On Days 2 to 14, participants will take 2 tablets of Placebo at bedtime. The minimum dosage will be 2 tablets daily at bedtime, increasing, when indicated, to the maximal dosage of 4 tablets per day on Days 3 to 14.

Trial Locations (8)

33016

Empire Clinical Research, LLC, Miami Lakes

33165

Medical Professional CR Center, Miami

43213

Complete Healthcare for Women, Columbus

49008

Western Michigan University Homer Stryker M.D. School of Medicine, Kalamazoo

85712

Watching Over Mothers and Babies, Tucson

90011

Clinica Del Socorro Medical Group, Inc., Los Angeles

90650

Futura Research, Norwalk

07753

Jersey Shore University Medical Center, Neptune City

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Premier Research Group plc

UNKNOWN

lead

Duchesnay Inc.

INDUSTRY

NCT02045901 - A Multicenter Trial of the Efficacy and Safety of Diclegis® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents | Biotech Hunter | Biotech Hunter