{"id":"naproxen-esomeprazole","safety":{"commonSideEffects":[{"rate":null,"effect":"Dyspepsia"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Nausea"}]},"_chembl":{"chemblId":"CHEMBL5314366","moleculeType":"Small molecule","molecularWeight":"769.20"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Naproxen inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation, pain, and fever. Esomeprazole suppresses gastric acid secretion by inhibiting the H+/K+-ATPase pump in gastric parietal cells, protecting the gastrointestinal mucosa from NSAID-related damage and ulceration.","oneSentence":"Naproxen-esomeprazole combines a nonsteroidal anti-inflammatory drug (NSAID) with a proton pump inhibitor to reduce inflammation and pain while protecting the stomach from NSAID-induced ulcers.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:56:37.187Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Osteoarthritis, rheumatoid arthritis, and other chronic pain conditions with reduced risk of NSAID-induced gastrointestinal ulcers"}]},"trialDetails":[{"nctId":"NCT06903585","phase":"PHASE2","title":"Non Steroidal Anti-inflammatory Drugs in the Prevention of Bone Pain Flares After Palliative Radiotherapy","status":"NOT_YET_RECRUITING","sponsor":"American University of Beirut Medical Center","startDate":"2025-04","conditions":"Bone Pain Flare, Bone Metastasis","enrollment":385},{"nctId":"NCT01544114","phase":"PHASE4","title":"A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA)","status":"COMPLETED","sponsor":"Amgen","startDate":"2012-04","conditions":"Juvenile Idiopathic Arthritis (JIA)","enrollment":46},{"nctId":"NCT03092193","phase":"PHASE4","title":"Pharmacogenetic and Pharmacokinetics of Naproxen and Associated Naproxen-esomeprazole","status":"COMPLETED","sponsor":"University of Sao Paulo","startDate":"2017-03-01","conditions":"Poor Metabolizer Due to Cytochrome P450 CYP2C9 Variant, Poor Metabolizer Due to Cytochrome p450 CYP2C19 Variant","enrollment":8},{"nctId":"NCT01670552","phase":"PHASE3","title":"Evaluation of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients","status":"COMPLETED","sponsor":"EMS","startDate":"2016-02-17","conditions":"Acute and Chronic Inflammation, Dyspepsia","enrollment":490},{"nctId":"NCT00153660","phase":"PHASE3","title":"Celecoxib Versus Naproxen for Prevention of Recurrent Ulcer Bleeding in Arthritis Patients","status":"COMPLETED","sponsor":"Chinese University of Hong Kong","startDate":"2005-06","conditions":"Arthritis, Cardiovascular Diseases, Cerebrovascular Disorders","enrollment":514},{"nctId":"NCT02494856","phase":"PHASE4","title":"Comparison of the Clinical Efficacy of Naproxen, Associated or Not With Esomeprazol, in Lower Third Molar Removal","status":"COMPLETED","sponsor":"Giovana Maria Weckwerth","startDate":"2014-10","conditions":"Pain, Other Surgical Procedures, Impacted Third Molar Tooth","enrollment":50},{"nctId":"NCT02307305","phase":"PHASE2","title":"Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?","status":"UNKNOWN","sponsor":"Hanyang University Seoul Hospital","startDate":"2014-08","conditions":"Neuropathic Pain","enrollment":168},{"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":"NCT01358383","phase":"PHASE1","title":"Assessment of Pharmacokinetics of a Single Oral Dose of VIMOVO in Healthy Adult Volunteers","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2011-05","conditions":"Juvenile Idiopathic Arthritis","enrollment":28},{"nctId":"NCT00664560","phase":"PHASE3","title":"Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis","status":"COMPLETED","sponsor":"POZEN","startDate":"2008-04","conditions":"Osteoarthritis","enrollment":614},{"nctId":"NCT00665431","phase":"PHASE3","title":"Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis","status":"COMPLETED","sponsor":"POZEN","startDate":"2008-04","conditions":"Osteoarthritis","enrollment":610},{"nctId":"NCT01331993","phase":"PHASE1","title":"A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2011-09","conditions":"Healthy Volunteers, Bioequivalence","enrollment":36},{"nctId":"NCT01129011","phase":"PHASE3","title":"Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen","status":"COMPLETED","sponsor":"POZEN","startDate":"2007-09","conditions":"Gastric Ulcer","enrollment":420},{"nctId":"NCT00527787","phase":"PHASE3","title":"Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen","status":"COMPLETED","sponsor":"POZEN","startDate":"2007-09","conditions":"Gastric Ulcer","enrollment":434},{"nctId":"NCT01094483","phase":"PHASE1","title":"A Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN400 and Low Dose Aspirin","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2010-03","conditions":"Platelet Inhibition","enrollment":40},{"nctId":"NCT00594854","phase":"PHASE3","title":"Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec","status":"TERMINATED","sponsor":"POZEN","startDate":"2007-09","conditions":"Gastric Ulcer","enrollment":20},{"nctId":"NCT00527904","phase":"PHASE3","title":"A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 (VIMOVO)","status":"COMPLETED","sponsor":"POZEN","startDate":"2007-03","conditions":"Gastric Ulcer","enrollment":239},{"nctId":"NCT00992381","phase":"PHASE1","title":"Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2009-09","conditions":"Healthy","enrollment":24},{"nctId":"NCT00749385","phase":"PHASE1","title":"A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels","status":"COMPLETED","sponsor":"POZEN","startDate":"2008-08","conditions":"Arthritis","enrollment":40},{"nctId":"NCT00676442","phase":"PHASE1","title":"Study Evaluating the Effect of Food on the Bioavailability of PN400 Components","status":"COMPLETED","sponsor":"POZEN","startDate":"2008-05","conditions":"Arthritis","enrollment":24},{"nctId":"NCT00692055","phase":"PHASE1","title":"Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations","status":"COMPLETED","sponsor":"POZEN","startDate":"2008-06","conditions":"Arthritis","enrollment":30},{"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":"NCT00599404","phase":"PHASE1","title":"PK Study to Evaluate Esomeprazole Plasma Levels Following Administration of PN 400","status":"COMPLETED","sponsor":"POZEN","startDate":"2008-01","conditions":"Healthy","enrollment":18}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":21,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["CYP2C9","CYP2C19"],"phase":"marketed","status":"active","brandName":"Naproxen-esomeprazole","genericName":"Naproxen-esomeprazole","companyName":"University of Sao Paulo","companyId":"university-of-sao-paulo","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Naproxen-esomeprazole combines a nonsteroidal anti-inflammatory drug (NSAID) with a proton pump inhibitor to reduce inflammation and pain while protecting the stomach from NSAID-induced ulcers. Used for Osteoarthritis, rheumatoid arthritis, and other chronic pain conditions with reduced risk of NSAID-induced gastrointestinal ulcers.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}