{"id":"diclofenac-test-upper-dose","safety":{"commonSideEffects":[{"rate":"10-20","effect":"Gastrointestinal upset (nausea, dyspepsia, abdominal pain)"},{"rate":"5-10","effect":"Headache"},{"rate":"3-5","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":"Diclofenac blocks both COX-1 and COX-2 enzymes, which are responsible for producing prostaglandins that mediate inflammation, pain, and fever. By reducing prostaglandin levels, diclofenac provides analgesic and anti-inflammatory effects. The 'upper dose' designation in this Phase 3 trial likely refers to evaluation of a higher dosing regimen compared to standard formulations.","oneSentence":"Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis and decrease inflammation and pain.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:09:32.786Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute pain management (Phase 3 trial indication for upper dose formulation)"},{"name":"Chronic inflammatory conditions such as osteoarthritis or rheumatoid arthritis"}]},"trialDetails":[{"nctId":"NCT01462435","phase":"PHASE3","title":"Study of Diclofenac Capsules to Treat Pain Following Bunionectomy","status":"COMPLETED","sponsor":"Iroko Pharmaceuticals, LLC","startDate":"2011-10","conditions":"Other Acute Postoperative Pain","enrollment":428},{"nctId":"NCT00985439","phase":"PHASE2","title":"Study of Diclofenac Capsules to Treat Dental Pain","status":"COMPLETED","sponsor":"Iroko Pharmaceuticals, LLC","startDate":"2009-09","conditions":"Dental Pain","enrollment":202}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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":"Diclofenac Test (upper dose)","genericName":"Diclofenac Test (upper dose)","companyName":"Iroko Pharmaceuticals, LLC","companyId":"iroko-pharmaceuticals-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis and decrease inflammation and pain. Used for Acute pain management (Phase 3 trial indication for upper dose formulation), Chronic inflammatory conditions such as osteoarthritis or rheumatoid arthritis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}