CLINICAL TRIALS PROFILE FOR ONDANSETRON HYDROCHLORIDE
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505(b)(2) Clinical Trials for Ondansetron Hydrochloride
| 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? |
| OTC | NCT01691690 ↗ | Analgesic Effect of IV Acetaminophen in Tonsillectomies | Completed | Nationwide Children's Hospital | Phase 2 | 2012-10-01 | Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate pain for pediatric patients. Its common use (particularly in oral form) is underscored by its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses. Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated, these mechanisms appear to be multi-factorial and include central inhibition of the cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from arachidonic acid, interference with serotonergic descending pain pathways, indirect activation of cannabinoid 1 (CB1) receptors and inhibition of nitric oxide pathways through N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known is that of central inhibition of COX enzymes by which the decreased production of prostaglandins diminish the release of excitatory transmitters of substance P and glutamate which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011). To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et al, 2009; Hong et al, 2010). |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Ondansetron Hydrochloride
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00000289 ↗ | Role of Metabolites in Nicotine Dependence (3) - 6 | Completed | University of Minnesota | Phase 2 | 1998-05-01 | The purpose of this study is to determine the effects of various doses of ondansetron transdermal nicotine replacement on tobacco withdrawal symptoms. |
| NCT00000289 ↗ | Role of Metabolites in Nicotine Dependence (3) - 6 | Completed | University of Minnesota - Clinical and Translational Science Institute | Phase 2 | 1998-05-01 | The purpose of this study is to determine the effects of various doses of ondansetron transdermal nicotine replacement on tobacco withdrawal symptoms. |
| NCT00000289 ↗ | Role of Metabolites in Nicotine Dependence (3) - 6 | Completed | National Institute on Drug Abuse (NIDA) | Phase 2 | 1998-05-01 | The purpose of this study is to determine the effects of various doses of ondansetron transdermal nicotine replacement on tobacco withdrawal symptoms. |
| NCT00000443 ↗ | Ondansetron Treatment for Alcoholism | Completed | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Phase 2 | 1969-12-31 | The purpose of this study is to: a) evaluate the effectiveness of ondansetron (Zofran) in the treatment of alcohol dependent patients; b) investigate whether early versus late onset alcoholism predicts treatment outcome; and c) determine whether the early and late onset groups respond differently to treatment. Individuals will be "typed" into early onset and late onset alcoholism groups. Individuals will be randomly assigned to a 12-week outpatient treatment program. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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