{"id":"diclofenac-sodium-active-topical-patch","safety":{"commonSideEffects":[{"rate":null,"effect":"Application site reactions (erythema, pruritus, irritation)"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Gastrointestinal upset (if systemic absorption occurs)"}]},"_chembl":{"chemblId":"CHEMBL1034","moleculeType":"Small molecule","molecularWeight":"318.14"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Diclofenac sodium works by blocking COX-1 and COX-2 enzymes, which are responsible for producing prostaglandins that mediate inflammation, pain, and fever. When formulated as a topical patch, the drug is delivered directly to affected tissues, allowing local anti-inflammatory and analgesic effects while minimizing systemic exposure compared to oral formulations. This localized delivery approach reduces the risk of gastrointestinal and cardiovascular adverse effects associated with systemic NSAID use.","oneSentence":"Diclofenac sodium is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain when applied topically.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:45:50.506Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Localized pain and inflammation associated with minor strains, sprains, and contusions"},{"name":"Osteoarthritis pain (localized)"}]},"trialDetails":[{"nctId":"NCT04683627","phase":"PHASE3","title":"A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee","status":"COMPLETED","sponsor":"Noven Pharmaceuticals, Inc.","startDate":"2020-12-29","conditions":"Osteoarthritis Pain of the Knee","enrollment":370},{"nctId":"NCT03277066","phase":"PHASE2","title":"A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis","status":"COMPLETED","sponsor":"Noven Pharmaceuticals, Inc.","startDate":"2017-09-07","conditions":"Osteoarthritis of the Knee","enrollment":289},{"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":"NCT02324270","phase":"PHASE3","title":"Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain","status":"COMPLETED","sponsor":"Actavis Inc.","startDate":"2014-05","conditions":"Ankle Sprain","enrollment":658},{"nctId":"NCT00931866","phase":"PHASE3","title":"Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED)","status":"COMPLETED","sponsor":"Cerimon Pharmaceuticals","startDate":"2009-04","conditions":"Acute Pain, Soft Tissue Injury","enrollment":407},{"nctId":"NCT00869180","phase":"PHASE3","title":"Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain","status":"COMPLETED","sponsor":"Cerimon Pharmaceuticals","startDate":"2009-02","conditions":"Acute Pain, Ankle Sprain","enrollment":219},{"nctId":"NCT00869063","phase":"PHASE3","title":"Diclofenac Patch for the Treatment of Acute Pain Due to Mild to Moderate Wrist Sprain, Strain or Contusion","status":"COMPLETED","sponsor":"Cerimon Pharmaceuticals","startDate":"2009-02","conditions":"Acute Pain","enrollment":214},{"nctId":"NCT00640705","phase":"PHASE2, PHASE3","title":"Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain","status":"TERMINATED","sponsor":"Cerimon Pharmaceuticals","startDate":"2008-01","conditions":"Ankle Sprain","enrollment":170},{"nctId":"NCT00640939","phase":"PHASE2, PHASE3","title":"Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis","status":"COMPLETED","sponsor":"Cerimon Pharmaceuticals","startDate":"2007-12","conditions":"Rotator Cuff Tendonitis, Bicipital Tendonitis, Subdeltoid Bursitis of the Shoulder","enrollment":308}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["HP-5000"],"phase":"phase_3","status":"active","brandName":"Diclofenac sodium active topical patch","genericName":"Diclofenac sodium active topical patch","companyName":"Noven Pharmaceuticals, Inc.","companyId":"noven-pharmaceuticals-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Diclofenac sodium is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain when applied topically. Used for Localized pain and inflammation associated with minor strains, sprains, and contusions, Osteoarthritis pain (localized).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}