The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy

November 22, 2021 updated by: Duchesnay Inc.

A Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Of The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Nausea and vomiting of pregnancy (NVP), also known as "morning sickness," is a common condition that affects a large percentage of pregnant women. The symptoms can range from mild nausea to severe nausea and vomiting for which a woman may need to be hospitalized. Nausea and vomiting of pregnancy can affect a woman's quality of life and ability to conduct daily activities.

Diclectin® is a combination of 10 mg doxylamine succinate (an antihistamine), and 10 mg pyridoxine hydrochloride (vitamin B6) in a delayed release tablet formulation. It has been commercially available in Canada for the management of NVP for over 25 years and has been prescribed to over 33 million pregnant women.

Presently, there is no Food Drug and Administration (FDA) approved drug on the market to treat the symptoms of NVP. This study will test the efficacy of Diclectin® (doxylamine 10 mg, pyridoxine 10 mg in a delayed-release formulation) for NVP.

Patients enrolled in the study will receive between 2 and 4 tablets of Diclectin® or placebo daily, depending on their symptoms for up to 14 days. Patients will assess their symptoms of nausea and vomiting daily using a standardized questionnaire.

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • Georgetown University Hospital
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center Physicians
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • National Naval Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Womens Hospital of University of Pittsburgh Medical Center
    • Texas
      • Galveston, Texas, United States, 77555-0587
        • University of Texas Medical Branch
      • Pasadena, Texas, United States, 77502
        • UTMB Pasadena Clinic
      • Pearland, Texas, United States, 77581
        • UTMB Regional Maternal & Child Health Program--Pearland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • The patient has signed a written informed consent to participate in the study and has agreed to follow dosing instructions and complete all required study visits.
  • The patient is a pregnant female age equal to or greater than 18 years old.
  • The patient's entry ultrasound indicates a viable pregnancy and confirms gestational age of the fetus is 7-14 weeks at the anticipated time of the first dose of study medication or placebo. If an ultrasound was done within 4 weeks of the admission visit, and results can be obtained, an additional ultrasound is not necessary.
  • The patient is suffering from NVP and has a Pregnancy Unique Quantification of Emesis (PUQE) score ≥6.
  • The patient has not responded to conservative management consisting of dietary/lifestyle advice according to the 2004 ACOG Practice Bulletin.
  • The patient agrees, if on a multivitamin, to continue on their current dose of multivitamin for the duration of the trial.
  • The patient does not plan termination of the pregnancy.

Exclusion Criteria:

  • The investigator confirms the patient's nausea and vomiting is of etiology other than Nausea and Vomiting of Pregnancy (NVP).
  • The patient has gestational trophoblastic disease or multifetal gestation.
  • The patient has a condition for which antihistamines, in the opinion of the investigator, are contraindicated (epilepsy, alcoholism, glaucoma, chronic lung disease, urinary retention, heart block, etc.).
  • The patient has used antihistamines, anticholinergics, dopamine antagonists, serotonin antagonists, ginger, or anti-emetic therapy (including acupressure, acupuncture, homeopathic remedies, medical hypnosis, relief bands etc) to treat NVP in the previous 48 hours or plans to do so during the study .
  • The patient is using drugs that have anticholinergic activity (e.g., tricyclic antidepressants).
  • The patient is taking multivitamins containing more than 10 mg of vitamin B6, or plans to do so during the study.
  • The patient is taking supplementary vitamin B6 in addition to any multivitamin preparation, or plans to do so during the study.
  • The patient is currently drinking any amount of alcohol.
  • The patient has any condition that might interfere with the conduct of the study.
  • The patient is likely to be unable to comply with study procedures because of inadequate cognitive skills.
  • The patient has received an investigational drug within 30 days before enrollment in this study or is scheduled to receive an investigational drug during the course of this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diclectin®
Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
Drug: doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg
up to 4 tablets daily, titrated according to the protocol
Other Names:
  • Diclectin®
Placebo Comparator: Placebo
Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
Drug: Placebo
2 to 4 tablets daily titrated according to the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diclectin Versus Placebo for Treatment of Nausea and Vomiting of Pregnancy (NVP) as Measured by the Change in Pregnancy Unique-Quantification of Emesis (PUQE) Overall Score of Symptoms From Baseline (Day 1) to End of Study Visit (Day 15).
Time Frame: Baseline (Day 1) to End of Study Visit Day 15 (± 1 day)
The objective of this double-blind, randomized, placebo-controlled study was to assess the efficacy, safety, and tolerability of oral Diclectin® in the treatment of nausea and vomiting of pregnancy (NVP) as measured by the Pregnancy Unique-Quantification of Emesis (PUQE) overall score of symptoms from baseline (Day 1) to end of study visit (Day 15). The PUQE score measured hours of nausea, number of times vomiting, and number of times retching for a TOTAL overall score of symptoms on a scale rated from 3 (no symptoms) to 15 (most severe).
Baseline (Day 1) to End of Study Visit Day 15 (± 1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duchesnay Inc.

Collaborators

Premier Research Group plc

Investigators

  • Study Director: Liubov Gargaun, M.D., Duchesnay Inc.
  • Principal Investigator: Gideon Koren, M.D., Motherisk Program, University of Toronto
  • Principal Investigator: Gary Hankins, M.D., University of Texas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

January 29, 2008

First Submitted That Met QC Criteria

January 30, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Actual)

November 23, 2021

Last Update Submitted That Met QC Criteria

November 22, 2021

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIC-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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