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Last Updated: June 26, 2022

CLINICAL TRIALS PROFILE FOR ZOFRAN ODT


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505(b)(2) Clinical Trials for Zofran Odt

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 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 >Phase >Start Date >Summary

All Clinical Trials for Zofran Odt

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT00006205 ↗ Alcohol Dependency Study: Combining Medication Treatment for Alcoholism Unknown status National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 2 2005-03-01 The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.
NCT00006205 ↗ Alcohol Dependency Study: Combining Medication Treatment for Alcoholism Unknown status Bankole Johnson Phase 2 2005-03-01 The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zofran Odt

Condition Name

Condition Name for Zofran Odt
Intervention Trials
Nausea 17
Healthy 16
Vomiting 14
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Condition MeSH

Condition MeSH for Zofran Odt
Intervention Trials
Vomiting 54
Nausea 46
Postoperative Nausea and Vomiting 26
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Clinical Trial Locations for Zofran Odt

Trials by Country

Trials by Country for Zofran Odt
Location Trials
United States 144
Canada 32
Germany 11
India 9
Italy 7
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Trials by US State

Trials by US State for Zofran Odt
Location Trials
Texas 27
California 12
New York 11
Florida 8
Virginia 7
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Clinical Trial Progress for Zofran Odt

Clinical Trial Phase

Clinical Trial Phase for Zofran Odt
Clinical Trial Phase Trials
Phase 4 36
Phase 3 13
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Zofran Odt
Clinical Trial Phase Trials
Completed 115
Terminated 15
Recruiting 11
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Clinical Trial Sponsors for Zofran Odt

Sponsor Name

Sponsor Name for Zofran Odt
Sponsor Trials
M.D. Anderson Cancer Center 11
Merck Sharp & Dohme Corp. 11
National Institute on Alcohol Abuse and Alcoholism (NIAAA) 7
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Sponsor Type

Sponsor Type for Zofran Odt
Sponsor Trials
Other 194
Industry 64
NIH 18
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