CLINICAL TRIALS PROFILE FOR DOXYLAMINE SUCCINATE
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505(b)(2) Clinical Trials for DOXYLAMINE SUCCINATE
| 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 | >Sponsor | >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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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