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The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy

NCT00614445 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2021-11-23

Study results available
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Summary

The purpose of this study is to determine whether Diclectin® (doxylamine succinate USP 10 mg and pyridoxine HCl 10 mg) is more effective at controlling the nausea and vomiting of pregnancy than a placebo.

Conditions

  • Nausea and Vomiting of Pregnancy

Interventions

DRUG

doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg

up to 4 tablets daily, titrated according to the protocol

DRUG

Placebo

2 to 4 tablets daily titrated according to the protocol

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Duchesnay Inc.

    lead INDUSTRY

Principal Investigators

  • Liubov Gargaun, M.D. · Duchesnay Inc.

  • Gideon Koren, M.D. · Motherisk Program, University of Toronto

  • Gary Hankins, M.D. · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-07-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00614445 on ClinicalTrials.gov