{"id":"vehicle-diclofenac-sodium-topical-gel","safety":{"commonSideEffects":[{"rate":"null","effect":"Skin burning sensation"},{"rate":"null","effect":"Skin irritation"}]},"_chembl":{"chemblId":"CHEMBL1034","moleculeType":"Small molecule","molecularWeight":"318.14"},"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"Diclofenac sodium is a nonsteroidal anti-inflammatory drug (NSAID) that selectively inhibits COX-2, an enzyme responsible for the production of prostaglandins, which are mediators of inflammation and pain. By inhibiting COX-2, diclofenac sodium reduces the production of prostaglandins, leading to decreased inflammation and pain. This mechanism of action is responsible for the therapeutic effects of diclofenac sodium in treating pain and inflammation.","oneSentence":"Diclofenac sodium works by inhibiting the enzyme cyclooxygenase (COX), which is involved in the production of prostaglandins, leading to reduced inflammation and pain.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:40:18.719Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Topical treatment of actinic keratosis"}]},"trialDetails":[{"nctId":"NCT07079969","phase":"PHASE2","title":"Effects of Photobiomodulation and Topical Diclofenac on Inflammation and Pain in Knee Osteoarthritis (EPIC-KO)","status":"NOT_YET_RECRUITING","sponsor":"University of Florida","startDate":"2026-04","conditions":"Knee Pain Chronic","enrollment":32},{"nctId":"NCT03172780","phase":"PHASE3","title":"A Bioequivalence Study Using Clinical Endpoint for Diclofenac Sodium Gel 1% in Osteoarthritis Knee\"","status":"COMPLETED","sponsor":"Mylan Pharmaceuticals Private Limited","startDate":"2017-05-24","conditions":"Osteoarthritis, Knee","enrollment":1220},{"nctId":"NCT02121002","phase":"PHASE3","title":"Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee","status":"COMPLETED","sponsor":"Amneal Pharmaceuticals, LLC","startDate":"2014-04","conditions":"Osteoarthritis","enrollment":1176},{"nctId":"NCT01962987","phase":"PHASE3","title":"A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis","status":"COMPLETED","sponsor":"Actavis Inc.","startDate":"2013-03","conditions":"Actinic Keratosis","enrollment":476},{"nctId":"NCT02952898","phase":"PHASE3","title":"Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses","status":"COMPLETED","sponsor":"Balmoral Medical company","startDate":"2016-10-27","conditions":"Actinic Keratosis","enrollment":665},{"nctId":"NCT01119898","phase":"PHASE2","title":"Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis","status":"COMPLETED","sponsor":"Mallinckrodt","startDate":"2010-08-02","conditions":"Osteoarthritis of the Knee","enrollment":260},{"nctId":"NCT01742663","phase":"PHASE1","title":"A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® Gel 3% in the Treatment of Actinic Keratosis","status":"COMPLETED","sponsor":"Sun Pharmaceutical Industries, Inc.","startDate":"2012-10","conditions":"Actinic Keratosis","enrollment":435},{"nctId":"NCT00426621","phase":"PHASE3","title":"Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis","status":"COMPLETED","sponsor":"Novartis","startDate":"2006-11","conditions":"Osteoarthritis of the Knee","enrollment":420},{"nctId":"NCT00441051","phase":"PHASE3","title":"Efficacy and Safety of Diclofenac Sodium (0.1%) Gel in Patients With UV Induced Painful Sunburn","status":"COMPLETED","sponsor":"Novartis","startDate":"2006-11","conditions":"Sunburn","enrollment":45}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"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":"Vehicle Diclofenac Sodium Topical Gel","genericName":"Vehicle Diclofenac Sodium Topical Gel","companyName":"Amneal Pharmaceuticals, LLC","companyId":"amneal-pharmaceuticals-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Diclofenac sodium works by inhibiting the enzyme cyclooxygenase (COX), which is involved in the production of prostaglandins, leading to reduced inflammation and pain. Used for Topical treatment of actinic keratosis.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}