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Last Updated: October 26, 2021

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CLINICAL TRIALS PROFILE FOR DOXYLAMINE SUCCINATE

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505(b)(2) Clinical Trials for Doxylamine Succinate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00796315 ↗ Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children Completed Consumer Healthcare Products Association Phase 1 2008-12-01 The primary goal of this study is to characterize the pharmacokinetics of doxylamine succinate in children ages 2 to < 18 years. Once characterized, these pediatric pharmacokinetic data will be pooled with historical adult PK data from other studies to assess whether the existing Over-the-Counter (OTC)doses provide comparable systemic drug exposure as that associated with efficacy in adults.
OTC NCT00796315 ↗ Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children Completed Procter and Gamble Phase 1 2008-12-01 The primary goal of this study is to characterize the pharmacokinetics of doxylamine succinate in children ages 2 to < 18 years. Once characterized, these pediatric pharmacokinetic data will be pooled with historical adult PK data from other studies to assess whether the existing Over-the-Counter (OTC)doses provide comparable systemic drug exposure as that associated with efficacy in adults.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Doxylamine Succinate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00293644 ↗ Pre-emptive Treatment of Severe Nausea and Vomiting of Pregnancy Completed Duchesnay Inc. Phase 3 2006-02-01 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.
NCT00293644 ↗ Pre-emptive Treatment of Severe Nausea and Vomiting of Pregnancy Completed The Hospital for Sick Children Phase 3 2006-02-01 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.
NCT00614445 ↗ The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy Completed Premier Research Group plc Phase 3 2008-01-01 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.
NCT00614445 ↗ The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy Completed Duchesnay Inc. Phase 3 2008-01-01 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.
NCT00796315 ↗ Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children Completed Consumer Healthcare Products Association Phase 1 2008-12-01 The primary goal of this study is to characterize the pharmacokinetics of doxylamine succinate in children ages 2 to < 18 years. Once characterized, these pediatric pharmacokinetic data will be pooled with historical adult PK data from other studies to assess whether the existing Over-the-Counter (OTC)doses provide comparable systemic drug exposure as that associated with efficacy in adults.
NCT00796315 ↗ Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children Completed Procter and Gamble Phase 1 2008-12-01 The primary goal of this study is to characterize the pharmacokinetics of doxylamine succinate in children ages 2 to < 18 years. Once characterized, these pediatric pharmacokinetic data will be pooled with historical adult PK data from other studies to assess whether the existing Over-the-Counter (OTC)doses provide comparable systemic drug exposure as that associated with efficacy in adults.
NCT00857987 ↗ Effectiveness and Safety of the of Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup in Improvement of Symptoms Resulting From Acute Respiratory Infections. Unknown status Azidus Brasil Phase 3 2010-04-01 Evaluate the improvement of the common cold with the use of medication
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Doxylamine Succinate

Condition Name

Condition Name for Doxylamine Succinate
Intervention Trials
Nausea and Vomiting of Pregnancy 2
Hyperemesis Gravidarum 1
Bioavailability 1
Allergic Rhinitis 1
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Condition MeSH

Condition MeSH for Doxylamine Succinate
Intervention Trials
Vomiting 3
Nausea 2
Respiratory Tract Infections 1
Pregnancy Complications 1
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Clinical Trial Locations for Doxylamine Succinate

Trials by Country

Trials by Country for Doxylamine Succinate
Location Trials
United States 10
China 6
Brazil 1
Canada 1
Mexico 1
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Trials by US State

Trials by US State for Doxylamine Succinate
Location Trials
District of Columbia 2
Ohio 1
North Carolina 1
Missouri 1
Louisiana 1
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Clinical Trial Progress for Doxylamine Succinate

Clinical Trial Phase

Clinical Trial Phase for Doxylamine Succinate
Clinical Trial Phase Trials
Phase 3 4
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Doxylamine Succinate
Clinical Trial Phase Trials
Completed 4
Not yet recruiting 1
Unknown status 1
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Clinical Trial Sponsors for Doxylamine Succinate

Sponsor Name

Sponsor Name for Doxylamine Succinate
Sponsor Trials
Duchesnay Inc. 2
Heilongjiang provincial hospital 1
Ningxia Hui Autonomous Region Hospital of TCM 1
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Sponsor Type

Sponsor Type for Doxylamine Succinate
Sponsor Trials
Other 16
Industry 7
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