CLINICAL TRIALS PROFILE FOR DOXYLAMINE SUCCINATE

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.

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.

Clinical Trial Conditions for DOXYLAMINE SUCCINATE

Condition Name

Condition Name for DOXYLAMINE SUCCINATE
Intervention	Trials
Nausea and Vomiting of Pregnancy	2
Allergic Rhinitis	1
Bioavailability	1

Condition MeSH

Condition MeSH for DOXYLAMINE SUCCINATE
Intervention	Trials
Vomiting	3
Nausea	2
Communicable Diseases	1

Clinical Trial Locations for DOXYLAMINE SUCCINATE

Trials by Country

Trials by Country for DOXYLAMINE SUCCINATE
Location	Trials
United States	10
China	6
Canada	1
Mexico	1
Brazil	1

Trials by US State

Trials by US State for DOXYLAMINE SUCCINATE
Location	Trials
District of Columbia	2
Louisiana	1
Kentucky	1
Texas	1
Pennsylvania	1

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

Clinical Trial Status

Clinical Trial Status for DOXYLAMINE SUCCINATE
Clinical Trial Phase	Trials
Completed	4
Withdrawn	1
Unknown status	1

Clinical Trial Sponsors for DOXYLAMINE SUCCINATE

Sponsor Name

Sponsor Name for DOXYLAMINE SUCCINATE
Sponsor	Trials
Duchesnay Inc.	2
First Affiliated Hospital of Heilongjiang Chinese Medicine University	1
Xuzhou Central Hospital	1

Sponsor Type

Sponsor Type for DOXYLAMINE SUCCINATE
Sponsor	Trials
Other	16
Industry	7