{"id":"diclofenac-hydroxyethylpyrrolidine","safety":{"commonSideEffects":[{"rate":"10-20","effect":"Gastrointestinal upset (nausea, dyspepsia)"},{"rate":"5-15","effect":"Abdominal pain"},{"rate":"5-10","effect":"Headache"},{"rate":"3-8","effect":"Dizziness"},{"rate":null,"effect":"Increased risk of cardiovascular events"},{"rate":null,"effect":"Increased risk of gastrointestinal bleeding"}]},"_chembl":null,"_fixedAt":"2026-03-30T16:24:48.456515","_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This drug blocks COX-1 and COX-2 enzymes, which are responsible for producing prostaglandins that mediate inflammation, pain, and fever. By reducing prostaglandin levels, it provides analgesic, anti-inflammatory, and antipyretic effects. The hydroxyethylpyrrolidine salt formulation is designed to improve solubility and bioavailability compared to standard diclofenac.","oneSentence":"Diclofenac hydroxyethylpyrrolidine is a non-steroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis and inflammation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:32:46.952Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute pain and inflammation"},{"name":"Rheumatoid arthritis"},{"name":"Osteoarthritis"},{"name":"Musculoskeletal disorders"}]},"_fixedFields":["sideEffects","modality→Small Molecule"],"trialDetails":[{"nctId":"NCT05171673","phase":"PHASE3","title":"Study of PK and Safety of the LicartTM Topical System in Pediatric and Adult Participants with Minor Soft Tissue Injury","status":"COMPLETED","sponsor":"IBSA Institut Biochimique SA","startDate":"2021-10-31","conditions":"Soft Tissue Injuries","enrollment":151},{"nctId":"NCT04976088","phase":"PHASE3","title":"Clinical Trial With Diclofenac Sodium Medicated Plaster in Patients With Impact Injuries of the Limbs","status":"COMPLETED","sponsor":"Fidia Farmaceutici s.p.a.","startDate":"2018-05-25","conditions":"Trauma Injury, Inflammation","enrollment":214},{"nctId":"NCT06061835","phase":"NA","title":"Non-contrast Magnetic Resonance Angiography in Deep Inferior Epigastric Perforator Flap Breast Reconstruction Planning","status":"UNKNOWN","sponsor":"I.M. Sechenov First Moscow State Medical University","startDate":"2023-05-06","conditions":"Breast Cancer, Postsurgical Acquired Absence of Organ","enrollment":135},{"nctId":"NCT04585321","phase":"PHASE1","title":"Comparative Bioavailability and Local Tolerability of Two Topical Diclofenac Plasters Applied Once and Twice a Day","status":"COMPLETED","sponsor":"Fidia Farmaceutici s.p.a.","startDate":"2017-11-28","conditions":"Bioequivalence Study","enrollment":52},{"nctId":"NCT03145259","phase":"EARLY_PHASE1","title":"Evaluation of Bioavailability of Diclofenac Dermal Products","status":"COMPLETED","sponsor":"University of Maryland, Baltimore","startDate":"2017-04-19","conditions":"Bioavailability","enrollment":12},{"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":"NCT01263652","phase":"NA","title":"Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients","status":"WITHDRAWN","sponsor":"Western Galilee Hospital-Nahariya","startDate":"2010-12-31","conditions":"Pain Relief","enrollment":""},{"nctId":"NCT01380353","phase":"EARLY_PHASE1","title":"Test Uniformity of Transdermal Drug Delivery to Breast Using Diclofenac Epolamine","status":"COMPLETED","sponsor":"Northwestern University","startDate":"2011-06","conditions":"Breast Cancer","enrollment":30},{"nctId":"NCT02132247","phase":"PHASE4","title":"Safety Study of Flector Patch in Children With Minor Soft Tissue Injuries","status":"COMPLETED","sponsor":"IBSA Institut Biochimique SA","startDate":"2014-05","conditions":"Athletic Injuries","enrollment":104},{"nctId":"NCT01350622","phase":"NA","title":"Efficacy of PENNSAID® for Pain Management in the Emergency Department","status":"WITHDRAWN","sponsor":"University of Utah","startDate":"2011-12","conditions":"Pain, Ankle Sprain","enrollment":""},{"nctId":"NCT01946984","phase":"PHASE1","title":"Diclofenac vs. Placebo in a Randomized Double Blind Controlled Trial in Post ERCP Pancreatitis","status":"COMPLETED","sponsor":"Specialized Arab Hospital","startDate":"2012-06","conditions":"Post-ERCP Acute Pancreatitis.","enrollment":182},{"nctId":"NCT01054820","phase":"PHASE4","title":"Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain","status":"COMPLETED","sponsor":"Pfizer","startDate":"2010-01","conditions":"Acute Back Strain","enrollment":123},{"nctId":"NCT00514748","phase":"NA","title":"A Bilateral Interconnected DIEP Flap Based on One Vessel Pedicle for Breast Reconstruction","status":"COMPLETED","sponsor":"Chinese Academy of Sciences","startDate":"2007-01","conditions":"Mammaplasty","enrollment":""},{"nctId":"NCT00284765","phase":"NA","title":"Management of the Sprained Ankle by Help of NSAID-Plaster","status":"UNKNOWN","sponsor":"Kolding Sygehus","startDate":"2006-02","conditions":"The Sprained Ankle","enrollment":200},{"nctId":"NCT00291590","phase":"PHASE3","title":"Diabetes Health Enhancement Program to Improve Health of People With Diabetes","status":"COMPLETED","sponsor":"Robert Wood Johnson Foundation","startDate":"2001-07","conditions":"Diabetes","enrollment":146}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":12,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Flector Patch","Voltaren, Abitren"],"phase":"marketed","status":"active","brandName":"Diclofenac hydroxyethylpyrrolidine","genericName":"Diclofenac hydroxyethylpyrrolidine","companyName":"IBSA Institut Biochimique SA","companyId":"ibsa-institut-biochimique-sa","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Diclofenac hydroxyethylpyrrolidine is a non-steroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis and inflammation. Used for Acute pain and inflammation, 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}}