NCT00293644

A Randomized, Open-Label, Study of Pre-emptive Diclectin® Treatment for Severe Nausea and Vomiting of Pregnancy

Completed Phase 3 Last updated 20 July 2016

What this trial tests

Phase 3 trial testing Diclectin® in Hyperemesis Gravidarum in 76 participants. Completed in 1 June 2015.

Timeline

1 February 2006

Primary endpoint
1 June 2012

1 June 2015

Quick facts

Lead sponsor	The Hospital for Sick Children
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	76
Start date	1 February 2006
Primary completion	1 June 2012
Estimated completion	1 June 2015
Sites	1 location across Canada

Drugs / interventions tested

• Diclectin®

Conditions studied

• Hyperemesis Gravidarum — all drugs for Hyperemesis Gravidarum →
• Pregnancy — all drugs for Pregnancy →

Sponsor

The Hospital for Sick Children

Who can join

18 and older, female only, with Hyperemesis Gravidarum or Pregnancy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Rate of severe NVP (defined by PUQE score >12), or HG (defined by PUQE score >12 plus hospitalization), as compared among the 3 groups.
  Time frame: Follow-up in all groups will be continued monthly until delivery. An additional follow-up telephone interview will be done at approximately 6 months post delivery.

Sponsor's own description

The purpose of this study is to determine whether pre-emptive use of a delayed release combination of pyridoxine hydrochloride and doxylamine succinate (Diclectin®), before eruption of symptoms of Nausea and vomiting of pregnancy and hyperemesis gravidarum, will reduce the incidence of severe forms of this syndrome/HG.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Preemptive treatment of nausea and vomiting of pregnancy: results of a randomized controlled trial.
   Maltepe C, Koren G. · · 2013 · cited 28× · PMID 23476657 · DOI 10.1155/2013/809787