CLINICAL TRIALS PROFILE FOR ZOFRAN ODT
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505(b)(2) Clinical Trials for Zofran Odt
| 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 | >Sponsor | >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. |
| NCT00027079 ↗ | Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron) | Completed | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Phase 2 | 2001-09-01 | This study will compare the effectiveness of ondansetron (Zofran) and naltrexone (ReVia) both alone and in combination in treating Early Onset Alcoholics versus Late Onset Alcoholics. All subjects will received standardized Cognitive Behavioral Therapy. Followup assessments will be completed at 1, 3, 6, and 9 months after treatment. |
| NCT00050167 ↗ | Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer | Completed | Roche Pharma AG | Phase 1 | 2002-11-01 | Primary Objectives: - Determine the impact of each regimen on the disease free and overall survival of patients with operable breast cancer. - Determine the ability of docetaxel/capecitabine to downstage primary breast cancer when administered in the neoadjuvant setting when compared with weekly paclitaxel. - Determine the ability of each regimen to enhance breast conservation therapy when administered in the neoadjuvant setting. (See protocol text for additional objectives and details). |
| NCT00050167 ↗ | Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer | Completed | M.D. Anderson Cancer Center | Phase 1 | 2002-11-01 | Primary Objectives: - Determine the impact of each regimen on the disease free and overall survival of patients with operable breast cancer. - Determine the ability of docetaxel/capecitabine to downstage primary breast cancer when administered in the neoadjuvant setting when compared with weekly paclitaxel. - Determine the ability of each regimen to enhance breast conservation therapy when administered in the neoadjuvant setting. (See protocol text for additional objectives and details). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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