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Last Updated: March 28, 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.
NCT01543945 ↗ Prevention Post Operative Nausea Vomiting in Ambulatory Gynecologic Laparoscopy Completed Prince of Songkla University Phase 2 2008-03-01 The purpose of this study is to compare the incidence of Postoperative nausea and vomiting between the intervention group who received multimodal antiemetic management and the control group who did not get this protocol.
NCT01890538 ↗ Comparison of Efficacy Between Piracetam and Dimenhydrinate in Patients With Peripheral Vertigo Completed Kocaeli University Phase 4 2013-06-01 This study aims to investigate efficacy of two different intravenous drugs (dimenhydrinate and piracetam) in the symptomatic management of peripheral vertigo. The patients will be randomized in two groups according to symptomatic treatment modalities: Dimenhydrinate (100 mg) and piracetam (2 g) will be given in 100 cc normal saline in 30 minutes. Each patient will be asked if her/his vertigo symptoms resolved or not, according to a numeric rating scale (0=no vertigo, 10=worst possible vertigo). The patient will be rate the intensity of symptoms in the following times: - Numeric rating scale (1 to 10): Admission - Numeric rating scale (1 to 10): After the study drug (No ambulation)* - Numeric rating scale (1 to 10): After the study drug (Ambulation)* - Ambulation refers to head movements or walking in the room, if applicable.
NCT02112578 ↗ Non Inferiority of Meclin® (Meclizine Chlorhydrate) Versus Dramin® (Dimenhydrinate) in Control of Acute Vertigo Symptoms From Peripheral Origin Unknown status Apsen Farmaceutica S.A. Phase 3 2016-11-01 - Evaluation of the non inferiority of Meclin (meclizine) versus Dramin (Dimenhydrinate) to treat the symptoms of acute vertigo from peripheral origin after up to 4 weeks of treatment; - Evaluation of impact on quality of life in vertigo; - Compare the intensity of daytime sleepiness in the two treatment groups; - Compare the efficacy of drugs in relieving each of the 10 symptoms that make up the VS; - Compare the duration of treatment in both treatment groups; - Compare Adehence; - Compare the level of satisfaction from each group from the investigators and the subjects; - Adverse events;
>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 6
Postoperative Pain 3
Nausea 2
Quality of Recovery 2
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Condition MeSH

Condition MeSH for dimenhydrinate
Intervention Trials
Vomiting 10
Postoperative Nausea and Vomiting 8
Nausea 8
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
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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 21
Industry 3
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