{"id":"comparator-ondansetron-iv","safety":{"commonSideEffects":[{"rate":"9-27","effect":"Headache"},{"rate":"5-11","effect":"Constipation"},{"rate":"3-8","effect":"Diarrhea"},{"rate":"5-13","effect":"Fatigue"},{"rate":"4-7","effect":"Dizziness"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ondansetron selectively antagonizes 5-hydroxytryptamine (serotonin) at the 5-HT3 receptor, which is located on vagal afferent nerves in the gastrointestinal tract and in the chemoreceptor trigger zone of the brain. By blocking these receptors, it prevents the transmission of emetic signals that would otherwise trigger the vomiting center, making it highly effective for chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea and vomiting (PONV).","oneSentence":"Ondansetron is a selective 5-HT3 receptor antagonist that blocks serotonin signaling in the chemoreceptor trigger zone and gastrointestinal tract to prevent nausea and vomiting.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:43:30.515Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of nausea and vomiting induced by chemotherapy"},{"name":"Prevention of postoperative nausea and vomiting"},{"name":"Prevention of radiation-induced nausea and vomiting"}]},"trialDetails":[{"nctId":"NCT07498751","phase":"PHASE1","title":"Phase I PK and Safety Study of Ondansetron Inhalation Powder","status":"COMPLETED","sponsor":"Luxena Pharmaceuticals, Inc.","startDate":"2025-03-13","conditions":"Postoperative Nausea and Vomiting","enrollment":24},{"nctId":"NCT07087925","phase":"NA","title":"Comparison of Haloperidol and Ondansetron in Reducing Postoperative Nausea and Vomiting in RA-SAB Patients","status":"COMPLETED","sponsor":"Rully Riyandika","startDate":"2025-01-15","conditions":"Postoperative Nausea and Vomiting (PONV), Subarachnoid Block, Spinal Anesthesia","enrollment":40},{"nctId":"NCT03262038","phase":"PHASE4","title":"Does IV Ondansetron Prevent Pruritus After Intrathecal Morphine in Pediatric Patients?","status":"TERMINATED","sponsor":"University of Michigan","startDate":"2017-12-07","conditions":"Pruritus, Nausea/Vomiting","enrollment":46},{"nctId":"NCT00285051","phase":"PHASE2","title":"Comparison of Delta-8-THC to Ondansetron in the Prevention of Acute Nausea From Moderately Emetogenic Chemotherapy","status":"TERMINATED","sponsor":"Rafa 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Cancer","enrollment":221},{"nctId":"NCT01697579","phase":"PHASE2","title":"Study of the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fosaprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Children (MK-0517-029)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2012-12-13","conditions":"Chemotherapy-induced Nausea and Vomiting","enrollment":240},{"nctId":"NCT03254459","phase":"PHASE2","title":"Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pain","status":"COMPLETED","sponsor":"INSYS Therapeutics Inc","startDate":"2017-09-12","conditions":"Pain, Postoperative","enrollment":100},{"nctId":"NCT02966041","phase":"NA","title":"Prophylactic Ondansetron in Post-op Cardiac Surgery Patients to Prevent Post-operative Nausea and Vomiting","status":"COMPLETED","sponsor":"University of British Columbia","startDate":"2018-03-06","conditions":"Postoperative Nausea and Vomiting","enrollment":186},{"nctId":"NCT01732458","phase":"PHASE2","title":"A Study to Evaluate Aprepitant for the Prevention of Post-Operative Nausea and Vomiting in Children (MK-0869-219)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2013-02-12","conditions":"Post-operative Nausea, Post-operative Vomiting","enrollment":229},{"nctId":"NCT00818259","phase":"PHASE1","title":"A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)","status":"TERMINATED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2009-02-05","conditions":"Chemotherapy-Induced Nausea and Vomiting","enrollment":92},{"nctId":"NCT01594749","phase":"PHASE3","title":"Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2012-09-24","conditions":"Chemotherapy-Induced Nausea and Vomiting (CINV)","enrollment":1015},{"nctId":"NCT00090246","phase":"PHASE3","title":"2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-091)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2004-05-13","conditions":"Postoperative Nausea and Vomiting","enrollment":922},{"nctId":"NCT00090155","phase":"PHASE3","title":"2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2003-09-26","conditions":"Postoperative Nausea and Vomiting","enrollment":805},{"nctId":"NCT00619359","phase":"PHASE3","title":"Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2008-02","conditions":"Chemotherapy-Induced Nausea and Vomiting (CINV)","enrollment":2322},{"nctId":"NCT01007500","phase":"PHASE4","title":"Effect of Dexamethasone Combined With Ondansetron on Postoperative Nausea and Vomiting in Patients With Patient-controlled Analgesia After Video-assisted Thoracoscopic Surgery","status":"COMPLETED","sponsor":"Yonsei University","startDate":"2009-09","conditions":"Nausea, Vomiting","enrollment":123},{"nctId":"NCT00231777","phase":"PHASE3","title":"A Study to Examine the Safety and Tolerability of MK0517 for the Prevention of Post-Operative Nausea and Vomiting (0517-015)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2005-07","conditions":"Post-Operative Nausea and Vomiting","enrollment":216},{"nctId":"NCT00891761","phase":"PHASE3","title":"A Study of IV Casopitant for the Prevention of Nausea and Vomiting Caused By Cisplatin-Based Highly Emetogenic Chemotherapy","status":"WITHDRAWN","sponsor":"GlaxoSmithKline","startDate":"2009-09","conditions":"Cancer, Chemotherapy-Induced Nausea and Vomiting, Nausea and Vomiting","enrollment":""},{"nctId":"NCT01442376","phase":"PHASE3","title":"Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients","status":"COMPLETED","sponsor":"Helsinn Healthcare SA","startDate":"2011-09","conditions":"Chemotherapy-Induced Nausea and Vomiting","enrollment":502},{"nctId":"NCT01395901","phase":"PHASE3","title":"Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients","status":"COMPLETED","sponsor":"Helsinn Healthcare SA","startDate":"2011-06","conditions":"Postoperative Nausea and Vomiting","enrollment":670},{"nctId":"NCT01659775","phase":"PHASE4","title":"Phase 4 Trial to Evaluate the Efficacy and Safety of Sancuso Patch in Chemotherapy-induced Nausea and Vomiting Associated With the Administration of Highly Emetogenic Chemotherapy (HEC)","status":"COMPLETED","sponsor":"LG Life Sciences","startDate":"2011-08","conditions":"Chemotherapy-induced Acute or Delayed Nausea and Vomiting (CINV)","enrollment":389}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":14,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Comparator: ondansetron IV","genericName":"Comparator: ondansetron IV","companyName":"Merck Sharp & Dohme LLC","companyId":"merck","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ondansetron IV is a small molecule used as a comparator in clinical trials for conditions such as chemotherapy-induced nausea and vomiting, post-operative nausea and vomiting, and pruritus. It has been compared to other interventions, including fosaprepitant dimeglumine, aprepitant, and dexamethasone, in studies such as NCT00619359.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}