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

NCT02045901 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2021-11-23

No results posted yet for this study

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).

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.

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Duchesnay Inc.

    lead INDUSTRY

Principal Investigators

  • Gideon Koren, MD · Hospital for Sick Children, 555 University Avenue, Toronto ON Canada, M5G-1X8

  • Gary Hankins, MD · University of Texas Medical Branch, Obstetrics/Gynecology, Route 0587, Galveston Texas USA, 77550-0587

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-03-31
Completion
2017-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02045901 on ClinicalTrials.gov