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in the Extent and Rate of Absorption of Doxylamine/Pyridoxine From 2 Different Products Under Fasting Conditions | Withdrawn | Grünenthal, S.A. | Phase 1 | 2019-06-01 | The purpose of the study is to investigate any difference in the extent and rate of absorption of doxylamine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. |
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