{"id":"comparator-naproxen-sodium","safety":{"commonSideEffects":[{"rate":"10-20","effect":"Gastrointestinal upset (nausea, dyspepsia)"},{"rate":"5-15","effect":"Abdominal pain"},{"rate":"5-10","effect":"Headache"},{"rate":"3-9","effect":"Dizziness"},{"rate":null,"effect":"Increased cardiovascular risk (with chronic use)"},{"rate":null,"effect":"Renal impairment (with chronic use)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Naproxen sodium blocks both COX-1 and COX-2 enzymes, which are responsible for producing prostaglandins that mediate inflammatory responses and pain signaling. The sodium salt formulation allows for faster absorption and more rapid onset of action compared to naproxen base. This mechanism makes it effective for acute and chronic pain relief, particularly in inflammatory conditions.","oneSentence":"Naproxen sodium is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation, pain, and fever.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:07:07.096Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Mild to moderate pain"},{"name":"Rheumatoid arthritis"},{"name":"Osteoarthritis"},{"name":"Menstrual cramps"},{"name":"Fever"}]},"trialDetails":[{"nctId":"NCT00092729","phase":"PHASE3","title":"An Investigational Drug Study in the Treatment of Primary Dysmenorrhea (0663-064)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2002-06-07","conditions":"Dysmenorrhea","enrollment":129},{"nctId":"NCT01208207","phase":"PHASE3","title":"A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) 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Treatment Of Multiple Migraine Attacks","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2005-10","conditions":"Migraine Disorders","enrollment":623},{"nctId":"NCT01016678","phase":"PHASE2, PHASE3","title":"Treximet Early Intervention Adolescent Migraine","status":"COMPLETED","sponsor":"Premiere Research Institute","startDate":"2010-03","conditions":"Migraine","enrollment":104},{"nctId":"NCT00966641","phase":"PHASE1, PHASE2","title":"Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults","status":"COMPLETED","sponsor":"PLx Pharma","startDate":"2009-08","conditions":"Healthy Volunteers","enrollment":34},{"nctId":"NCT00601458","phase":"PHASE1","title":"Bunionectomy Study (0000-063)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2007-07","conditions":"Acute Pain","enrollment":100},{"nctId":"NCT02355236","phase":"PHASE4","title":"Gastro-protective Effect and Pain Relief Effect of Naxozol Compared to Celecoxib in Patients With Osteoarthritis","status":"UNKNOWN","sponsor":"Severance Hospital","startDate":"2015-02","conditions":"Osteoarthritis","enrollment":106},{"nctId":"NCT01063920","phase":"PHASE2, PHASE3","title":"Rates of Gastric Ulcer by Endoscopy in Knee Osteoarthritis Patients Receiving LT-NS001 Versus Naprosyn®","status":"COMPLETED","sponsor":"Logical Therapeutics","startDate":"2010-02","conditions":"Osteoarthritis","enrollment":534},{"nctId":"NCT00750243","phase":"PHASE1","title":"Comparator Study of LT-NS001 in Healthy Subjects With Endoscopic Evaluation","status":"COMPLETED","sponsor":"Logical Therapeutics","startDate":"2008-09","conditions":"Healthy","enrollment":120},{"nctId":"NCT00665743","phase":"PHASE1","title":"Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations","status":"COMPLETED","sponsor":"POZEN","startDate":"2008-03","conditions":"Arthritis","enrollment":30},{"nctId":"NCT00652925","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA","status":"COMPLETED","sponsor":"Pfizer","startDate":"2002-10","conditions":"Arthritis, Juvenile Rheumatoid","enrollment":225}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":283,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["naproxen sodium"],"phase":"phase_3","status":"active","brandName":"Comparator: naproxen sodium","genericName":"Comparator: naproxen sodium","companyName":"Organon and Co","companyId":"organon-and-co","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Naproxen sodium is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation, pain, and fever. Used for Mild to moderate pain, Rheumatoid arthritis, Osteoarthritis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}