{"id":"placebo-followed-by-ondansetron","safety":{"commonSideEffects":[{"rate":"9-27%","effect":"Headache"},{"rate":"5-25%","effect":"Constipation"},{"rate":"3-15%","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 is a selective antagonist of serotonin 5-HT3 receptors, which are located on chemoreceptor trigger zone neurons and on the vagal afferent nerves of the gastrointestinal tract. By blocking these receptors, it prevents the transmission of emetic signals to the vomiting center in the brainstem. This mechanism makes it particularly effective for chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea and vomiting (PONV).","oneSentence":"Ondansetron blocks serotonin 5-HT3 receptors on chemoreceptor trigger zone and vagal afferent nerves to prevent nausea and vomiting.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:27:02.299Z","_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":"NCT05306899","phase":"PHASE3","title":"Multi-center RCT of IV Ketamine Efficacy and Safety in Chronic Daily Headaches","status":"RECRUITING","sponsor":"University Health Network, Toronto","startDate":"2022-06-01","conditions":"Chronic Daily Headache","enrollment":56},{"nctId":"NCT06007586","phase":"PHASE3","title":"Prevention and Treatment of CINV Caused by TC Regimen in Gynecological Malignant Tumor Patients","status":"COMPLETED","sponsor":"Sichuan Cancer Hospital and Research Institute","startDate":"2024-05-31","conditions":"Gynecological Tumor, Ovarian Cancer, Cervical Cancer","enrollment":143},{"nctId":"NCT06297499","phase":"PHASE1","title":"Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section","status":"RECRUITING","sponsor":"Wayne State University","startDate":"2024-08-22","conditions":"Pruritus Caused by Drug","enrollment":66},{"nctId":"NCT03747341","phase":"PHASE1","title":"Buprenorphine-Fentanyl Interaction Study","status":"COMPLETED","sponsor":"Indivior Inc.","startDate":"2018-03-22","conditions":"Healthy, Opioid Use","enrollment":22},{"nctId":"NCT02116530","phase":"PHASE3","title":"Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy","status":"COMPLETED","sponsor":"Alliance for Clinical Trials in Oncology","startDate":"2014-08-20","conditions":"Hematopoietic/Lymphoid Cancer, Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific","enrollment":401},{"nctId":"NCT03475693","phase":"EARLY_PHASE1","title":"A Cohort Study Evaluating the Efficacy of PO Magnesium in the Treatment of Acute Traumatic Brain Injury in Adolescents","status":"COMPLETED","sponsor":"Corewell Health South","startDate":"2017-09-01","conditions":"Concussion Post Syndrome","enrollment":17},{"nctId":"NCT06444737","phase":"NA","title":"Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia","status":"RECRUITING","sponsor":"Mongi Slim Hospital","startDate":"2023-11-30","conditions":"Post-Dural Puncture Headache","enrollment":300},{"nctId":"NCT05514483","phase":"PHASE4","title":"5-HT3 Receptor Antagonist and Respiratory Drive in Patients With ARDS","status":"UNKNOWN","sponsor":"Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal","startDate":"2022-11-10","conditions":"Acute Respiratory Distress Syndrome","enrollment":10},{"nctId":"NCT03182179","phase":"NA","title":"Efficacy of Ondansetron in LARS Treatment","status":"COMPLETED","sponsor":"Ente Ospedaliero Cantonale, Bellinzona","startDate":"2016-11-01","conditions":"Rectal Cancer","enrollment":48},{"nctId":"NCT02354703","phase":"PHASE2","title":"Pharmacogenetic Study of Ondansetron in Alcohol Use Disorder","status":"COMPLETED","sponsor":"University of Maryland, Baltimore","startDate":"2015-08","conditions":"Alcohol Use Disorder","enrollment":293},{"nctId":"NCT00918190","phase":"NA","title":"Late Onset Postoperative Nausea and Vomiting","status":"COMPLETED","sponsor":"King Khaled Eye Specialist Hospital","startDate":"2009-06","conditions":"Postoperative Nausea and Vomiting","enrollment":75},{"nctId":"NCT01346267","phase":"NA","title":"Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy","status":"COMPLETED","sponsor":"University of South Florida","startDate":"2011-05","conditions":"Central Nervous System Tumor, Pediatric, Chemotherapy-induced Nausea and Vomiting, Unspecified Childhood Solid Tumor, Protocol Specific","enrollment":187},{"nctId":"NCT00149734","phase":"PHASE3","title":"Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia","status":"COMPLETED","sponsor":"University of Colorado, Denver","startDate":"2005-01","conditions":"Schizophrenia","enrollment":8},{"nctId":"NCT01661335","phase":"PHASE3","title":"Efficacy of Aprepitant (Emend®) in Children","status":"COMPLETED","sponsor":"University of Oklahoma","startDate":"2012-06-01","conditions":"Nausea, Vomiting, Childhood Cancer","enrollment":19},{"nctId":"NCT01857232","phase":"PHASE2","title":"Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy","status":"COMPLETED","sponsor":"Acacia Pharma Ltd","startDate":"2013-10","conditions":"CINV","enrollment":342},{"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":"NCT02542384","phase":"PHASE2, PHASE3","title":"A Study Evaluating the Overall Pain Relief and Safety of Intravenous (IV) CR845 in Patients Undergoing Abdominal Surgery","status":"COMPLETED","sponsor":"Cara Therapeutics, Inc.","startDate":"2015-09","conditions":"Post Abdominal Surgery Pain","enrollment":451},{"nctId":"NCT01549652","phase":"NA","title":"5HT3 Antagonists to Treat Opioid Withdrawal and to Prevent the Progression of Physical Dependence","status":"COMPLETED","sponsor":"Stanford University","startDate":"2011-04","conditions":"Opioid Withdrawal, Physical Dependence","enrollment":133},{"nctId":"NCT01636947","phase":"PHASE4","title":"A Korean Study of Efficacy and Safety of Aprepitant-based Triple Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapy (Non-doxorubicin Hydrochloride [Adriamycin] and Cyclophosphamide Regimens) (MK-0869-225) (KMEC)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2012-12-12","conditions":"Nausea, Vomiting","enrollment":494},{"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":"NCT01870635","phase":"PHASE4","title":"Ondansetron Administration to WELL Children With Gastroenteritis Associated Vomiting in EDs in Pakistan","status":"COMPLETED","sponsor":"Dr. Stephen Freedman","startDate":"2014-05","conditions":"Dehydration, Gastroenteritis, Vomiting","enrollment":625},{"nctId":"NCT01870648","phase":"PHASE4","title":"Ondansetron Administration to Children With Gastroenteritis, Vomiting and SOME Dehydration in EDs in Pakistan","status":"COMPLETED","sponsor":"Dr. Stephen Freedman","startDate":"2014-05","conditions":"Dehydration, Gastroenteritis, Vomiting","enrollment":918},{"nctId":"NCT02614586","phase":"PHASE1","title":"Evaluation of TAK-058 and Ondansetron on P50 Auditory Gating in Participants With Stable Schizophrenia","status":"TERMINATED","sponsor":"Takeda","startDate":"2015-12","conditions":"Schizophrenia","enrollment":11},{"nctId":"NCT02085577","phase":"PHASE4","title":"The Effect of Intraoperative Ketamine on Opioid Consumption and Pain After Spine Surgery in Opioid-dependent Patients","status":"COMPLETED","sponsor":"Rigshospitalet, Denmark","startDate":"2014-05","conditions":"Postoperative Pain, Chronic Pain, Analgesics","enrollment":147},{"nctId":"NCT01205503","phase":"PHASE2","title":"Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and Tumor Necrosis Factor Alpha (TNF-α) Release","status":"COMPLETED","sponsor":"Mara Chambers","startDate":"2010-09","conditions":"Breast Cancer, Non-Hodgkin's Lymphoma","enrollment":32},{"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":"NCT00080444","phase":"PHASE3","title":"Study of Aprepitant (MK-0869) for Chemotherapy-Induced Nausea and Vomiting (CINV) in Adolescent Participants (MK-0869-097)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2004-04","conditions":"Vomiting","enrollment":50},{"nctId":"NCT00539721","phase":"PHASE2","title":"A Randomized Controlled Study of Rolapitant for the Prevention of Nausea and Vomiting Following Surgery (Study P04937AM1)(COMPLETED)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2007-10","conditions":"Postoperative Nausea and Vomiting","enrollment":619},{"nctId":"NCT01050270","phase":"PHASE4","title":"Scottish and Newcastle Anti-emetic Pre-treatment for Paracetamol Poisoning Study (SNAP)","status":"COMPLETED","sponsor":"University of Edinburgh","startDate":"2010-09","conditions":"Overdose","enrollment":222}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":265,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Zofran, Zuplenz"],"phase":"phase_3","status":"active","brandName":"Placebo followed by Ondansetron","genericName":"Placebo followed by Ondansetron","companyName":"University of Colorado, Denver","companyId":"university-of-colorado-denver","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ondansetron blocks serotonin 5-HT3 receptors on chemoreceptor trigger zone and vagal afferent nerves to prevent nausea and vomiting. Used for Prevention of nausea and vomiting induced by chemotherapy, Prevention of postoperative nausea and vomiting, Prevention of radiation-induced nausea and vomiting.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}