At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 280 enrolled
Drug / intervention
doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg +1 moredrug
Likely dose
doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Of The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy
In Brief
A Phase 3 clinical trial evaluating doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg and Placebo for Nausea and Vomiting of Pregnancy. Completed, enrolled 280 participants across 7 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNausea and Vomiting of Pregnancy
CountriesUnited States
CollaboratorsPremier Research
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedFeb 2008
Primary CompletionJul 2009
Study CompletionDec 2009
TodayJul 2026
First PostedFeb 13, 2008
Enrollment StartJan 1, 2008
Primary CompletionJul 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.4 years ago
Interventions
doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mgdrug
up to 4 tablets daily, titrated according to the protocol
Placebodrug
2 to 4 tablets daily titrated according to the protocol