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Last Updated: March 1, 2021

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CLINICAL TRIALS PROFILE FOR DIMENHYDRINATE

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505(b)(2) Clinical Trials for Dimenhydrinate

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 NCT00124787 A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis Completed Canadian Association of Emergency Physicians Phase 4 2005-04-01 Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis. RESEARCH QUESTION Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?
OTC NCT00124787 A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis Completed St. Justine's Hospital Phase 4 2005-04-01 Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis. RESEARCH QUESTION Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Dimenhydrinate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00124787 A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis Completed Canadian Association of Emergency Physicians Phase 4 2005-04-01 Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis. RESEARCH QUESTION Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?
NCT00124787 A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis Completed St. Justine's Hospital Phase 4 2005-04-01 Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis. RESEARCH QUESTION Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?
NCT00791960 Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting Completed Samuel Lunenfeld Research Institute, Mount Sinai Hospital N/A 2008-11-01 The purpose of this study will be to determine whether an intravenous dose of dimenhydrinate (also known as Gravol), given before the induction of spinal anesthesia, will decrease the incidence of intraoperative nausea and vomiting in patients undergoing Cesarean delivery. This medication is commonly given during and after the surgery if required, but it is not known whether a preventative dose will decrease the overall incidence of these side effects.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dimenhydrinate

Condition Name

Condition Name for Dimenhydrinate
Intervention Trials
Postoperative Nausea and Vomiting 4
Nausea 3
Vomiting 2
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Condition MeSH

Condition MeSH for Dimenhydrinate
Intervention Trials
Nausea 8
Vomiting 8
Postoperative Nausea and Vomiting 6
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Clinical Trial Locations for Dimenhydrinate

Trials by Country

Trials by Country for Dimenhydrinate
Location Trials
Brazil 6
Canada 5
Turkey 2
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Clinical Trial Progress for Dimenhydrinate

Clinical Trial Phase

Clinical Trial Phase for Dimenhydrinate
Clinical Trial Phase Trials
Phase 4 7
Phase 3 3
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Dimenhydrinate
Clinical Trial Phase Trials
Completed 9
Not yet recruiting 5
Recruiting 2
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Clinical Trial Sponsors for Dimenhydrinate

Sponsor Name

Sponsor Name for Dimenhydrinate
Sponsor Trials
Pontificia Universidade Catolica de Sao Paulo 2
Queen's University 1
St. Justine's Hospital 1
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Sponsor Type

Sponsor Type for Dimenhydrinate
Sponsor Trials
Other 16
Industry 3
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