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Last Updated: November 22, 2024

CLINICAL TRIALS PROFILE FOR DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE


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All Clinical Trials for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

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.
NCT03905564 ↗ A Study to Investigate Differences in the Extent and Rate of Absorption of Doxylamine/Pyridoxine From 2 Different Products Under Fasting Conditions Withdrawn Grünenthal, S.A. Phase 1 2019-06-01 The purpose of the study is to investigate any difference in the extent and rate of absorption of doxylamine between the test (investigational medicinal product [IMP]) and reference products that could impact the bioavailability of the medication when administered under fasting conditions.
NCT03905564 ↗ A Study to Investigate Differences in the Extent and Rate of Absorption of Doxylamine/Pyridoxine From 2 Different Products Under Fasting Conditions Withdrawn Grünenthal GmbH Phase 1 2019-06-01 The purpose of the study is to investigate any difference in the extent and rate of absorption of doxylamine between the test (investigational medicinal product [IMP]) and reference products that could impact the bioavailability of the medication when administered under fasting conditions.
NCT04401384 ↗ Effectiveness of Acupuncture and Doxylamine/Pyridoxine for Moderate to Severe Nausea and Vomiting in Pregnancy Completed Affiliated Hospital of Jiamusi Medical University Phase 3 2020-06-21 Nausea and vomiting in pregnancy (NVP) is one of the most common symptoms of pregnancy affecting 50-85% of women during the first half of pregnancy. Maternal morbidity is common and includes psychological effects, financial burden, clinical complications from nutritional deficiencies, gastrointestinal trauma, and in rare cases, neurological damage. As the main means of alternative treatment, economical and easy to obtain; the clinical efficacy of acupuncture treatment of this disease has low level of evidence and needs to be reconfirmed. Doxylamine vitamin B6 sustained release tablets (Diclectin, combination of doxylamine succinate (10mg) and pyridoxine hydrochloride (10mg) are The American College of Obstetricians and Gynecologists recommends with Level A evidence the use of vitamin B6 in combination with doxylamine as first-line pharmacotherapy for treatment of NVP. The efficacy and safety of Diclectin has been confirmed in many years of research, but there is no evidence of high-level evidence-based medicine for the Chinese population. The purpose of this multicenter, randomized, double-blind, placebo-controlled trial was to investigate the efficacy and safety of acupuncture versus Diclectin in the treatment of NVP. We hypothesis that: (1) Sham acupuncture and Diclectin (Arm B) is more effective than sham acupuncture and placebo (Arm D); (2) Active acupuncture and placebo (Arm C) is more effective than sham acupuncture and placebo (Arm D); (3) Sham acupuncture and diclectin (Arm B) have similar treatment effects with active acupuncture and placebo (Arm C); (4) There is no interaction (either synergistic or antagonistic effects) between the two interventions of active acupuncture and Diclectin in patients with NVP.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

Condition Name

Condition Name for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Intervention Trials
Nausea and Vomiting of Pregnancy 2
Bioavailability 1
Hyperemesis Gravidarum 1
Pregnancy 1
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Condition MeSH

Condition MeSH for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Intervention Trials
Vomiting 3
Nausea 2
Pregnancy Complications 1
Hyperemesis Gravidarum 1
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Clinical Trial Locations for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

Trials by Country

Trials by Country for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Location Trials
China 6
United States 4
Canada 1
Mexico 1
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Trials by US State

Trials by US State for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Location Trials
Texas 1
Pennsylvania 1
Maryland 1
District of Columbia 1
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Clinical Trial Progress for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Clinical Trial Phase Trials
Phase 3 3
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 3
Withdrawn 1
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Clinical Trial Sponsors for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Sponsor Trials
Duchesnay Inc. 2
Jixi Maternal and Child Health Hospital 1
The Hospital for Sick Children 1
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Sponsor Type

Sponsor Type for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Sponsor Trials
Other 15
Industry 5
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