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Last Updated: December 26, 2024

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.
NCT01524731 ↗ The Effect of Prophylactic Antiemetic Dexamethasone on Plasma Cortisol Levels Completed William Li Pi Shan N/A 2012-05-01 Dexamethasone is a synthetic corticosteroid that has been proven to be effective and relatively safe for the prophylaxis of the postoperative nausea and vomiting (PONV). However, little is known about its effect on the hypothalamic-pituitary-adrenal (HPA) axis after surgery. The investigators hypothesize that it will inhibit the normal physiologic HPA surge and reduce cortisol levels post-operatively ia a dose-dependant fashion. To answer this question, the investigators will conduct a randomized, double-blinded placebo-controlled trial with two different doses of dexamethasone in women undergoing elective gynecologic laparotomy.
>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 7
Postoperative Pain 3
Vomiting 2
Nausea 2
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Condition MeSH

Condition MeSH for DIMENHYDRINATE
Intervention Trials
Vomiting 11
Postoperative Nausea and Vomiting 9
Nausea 9
Dizziness 3
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Clinical Trial Locations for DIMENHYDRINATE

Trials by Country

Trials by Country for DIMENHYDRINATE
Location Trials
Canada 9
Brazil 7
Turkey 2
Thailand 1
Jamaica 1
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Clinical Trial Progress for DIMENHYDRINATE

Clinical Trial Phase

Clinical Trial Phase for DIMENHYDRINATE
Clinical Trial Phase Trials
Phase 4 9
Phase 3 3
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for DIMENHYDRINATE
Clinical Trial Phase Trials
Completed 12
Not yet recruiting 4
Unknown status 2
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Clinical Trial Sponsors for DIMENHYDRINATE

Sponsor Name

Sponsor Name for DIMENHYDRINATE
Sponsor Trials
Pontificia Universidade Catolica de Sao Paulo 3
William Li Pi Shan 1
Assiut University 1
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Sponsor Type

Sponsor Type for DIMENHYDRINATE
Sponsor Trials
Other 22
Industry 3
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