{"id":"colchicine-for-6-months","safety":{"commonSideEffects":[{"rate":"10-30","effect":"Diarrhea"},{"rate":"5-15","effect":"Nausea"},{"rate":"5-15","effect":"Abdominal pain"},{"rate":"1-5","effect":"Myopathy"},{"rate":"1-3","effect":"Neutropenia"},{"rate":"2-5","effect":"Elevated liver enzymes"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Colchicine disrupts microtubule dynamics, which impairs the movement and activation of neutrophils and other immune cells. This leads to decreased secretion of pro-inflammatory cytokines and chemokines, reducing the inflammatory cascade. The drug has been used for decades in gout and is being investigated for its anti-inflammatory effects in various cardiovascular and inflammatory conditions.","oneSentence":"Colchicine inhibits microtubule polymerization by binding to tubulin, thereby suppressing inflammatory cell migration and reducing production of inflammatory mediators.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:45:08.033Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute gout flares"},{"name":"Gout prophylaxis"},{"name":"Familial Mediterranean fever"},{"name":"Pericarditis (investigational)"}]},"trialDetails":[{"nctId":"NCT02939573","phase":"PHASE2","title":"A Randomized Multicenter Study for Isolated Skin Vasculitis","status":"RECRUITING","sponsor":"University of Pennsylvania","startDate":"2017-01-01","conditions":"Primary Cutaneous Vasculitis, Cutaneous Polyarteritis Nodosa, IgA Vasculitis","enrollment":90},{"nctId":"NCT04875702","phase":"PHASE4","title":"Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout","status":"RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2024-02-22","conditions":"Gout","enrollment":650},{"nctId":"NCT07130305","phase":"NA","title":"is There an Effect of Adding Body Vibration to Intake of Vitamin D on Some Outcomes of Familial Mediterranean Fever","status":"RECRUITING","sponsor":"Cairo University","startDate":"2025-05-08","conditions":"Familial Mediterranean Fever","enrollment":40},{"nctId":"NCT07130318","phase":"NA","title":"Mediterranean Diet in Familial Mediterranean Fever: Is Fatty Liver Affected by Addition of Aerobic Exercise","status":"RECRUITING","sponsor":"Cairo University","startDate":"2025-05-08","conditions":"Familial Mediterranean Fever, Non-Alcoholic Fatty Liver Disease","enrollment":40},{"nctId":"NCT06666335","phase":"PHASE4","title":"A Study to Evaluate Efficacy and Safety of Anakinra in Chinese Patients With Colchicine-resistent FMF","status":"NOT_YET_RECRUITING","sponsor":"Swedish Orphan Biovitrum","startDate":"2025-09-01","conditions":"Familial Mediterranean Fever (FMF )","enrollment":3},{"nctId":"NCT06158698","phase":"PHASE3","title":"CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine","status":"RECRUITING","sponsor":"Niguarda Hospital","startDate":"2023-11-14","conditions":"Cardiomyopathies, Myocarditis, Inflammatory Cardiomyopathy","enrollment":80},{"nctId":"NCT05253794","phase":"PHASE2, PHASE3","title":"Effect of Colchicine on the Progression of Aortic Valve Stenosis - a Pilot Study","status":"RECRUITING","sponsor":"Ottawa Heart Institute Research Corporation","startDate":"2022-07-01","conditions":"Aortic Stenosis, Inflammation","enrollment":24},{"nctId":"NCT03635957","phase":"PHASE4","title":"Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout","status":"COMPLETED","sponsor":"Amgen","startDate":"2018-09-26","conditions":"Gout","enrollment":14},{"nctId":"NCT03994731","phase":"PHASE4","title":"Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout","status":"COMPLETED","sponsor":"Amgen","startDate":"2019-06-13","conditions":"Gout","enrollment":152},{"nctId":"NCT06469528","phase":"PHASE3","title":"ESCALATion of Medical Therapy Following Multimodality Plaque Evaluation in High-risk Chronic Coronary Syndromes","status":"NOT_YET_RECRUITING","sponsor":"King's College Hospital NHS Trust","startDate":"2024-06-24","conditions":"Coronary Artery Disease","enrollment":50},{"nctId":"NCT05200052","phase":"PHASE4","title":"Effect of Colchicine On Left Ventricle Function After Anterior Myocardial Infarction Assessed By Speckle Tracking","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2022-02-01","conditions":"Anterior MI, Colchicine","enrollment":100},{"nctId":"NCT03226899","phase":"PHASE4","title":"A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment","status":"TERMINATED","sponsor":"Ironwood Pharmaceuticals, Inc.","startDate":"2017-07-19","conditions":"Gout, Chronic Kidney Disease (CKD)","enrollment":242},{"nctId":"NCT04377321","phase":"","title":"Colchicine Has Anti-diabetic Effect","status":"COMPLETED","sponsor":"Ministry of Health and Population, Egypt","startDate":"2019-10-10","conditions":"Treatment Adherence","enrollment":150},{"nctId":"NCT02162303","phase":"PHASE2","title":"Colchicine in Vascular Inflammation Assessed With PET Imaging","status":"COMPLETED","sponsor":"Montreal Heart Institute","startDate":"2014-05","conditions":"Atherosclerotic Vascular Disease","enrollment":106},{"nctId":"NCT04155879","phase":"NA","title":"Atrial Fibrillation Recurrence Following Cardioversion: the Role of Clinical Factors and Alpha Defensin Levels","status":"UNKNOWN","sponsor":"Hillel Yaffe Medical Center","startDate":"2019-11","conditions":"Atrial Fibrillation","enrollment":300},{"nctId":"NCT01112982","phase":"PHASE4","title":"An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.","status":"COMPLETED","sponsor":"University of South Florida","startDate":"2010-05","conditions":"Gout","enrollment":74},{"nctId":"NCT02500641","phase":"PHASE4","title":"Intensive Urate Lowering Therapy of Febuxostat Compared to Allopurinol on Cardiovascular Risk in Patients With Gout","status":"COMPLETED","sponsor":"Menarini International Operations Luxembourg SA","startDate":"2015-08-17","conditions":"Gout","enrollment":196},{"nctId":"NCT03659058","phase":"NA","title":"Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After SVR","status":"COMPLETED","sponsor":"Zagazig University","startDate":"2016-03-02","conditions":"Fibrosis, Liver","enrollment":400},{"nctId":"NCT01080131","phase":"PHASE3","title":"Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2010-03","conditions":"Acute Gout","enrollment":226},{"nctId":"NCT01029652","phase":"PHASE3","title":"Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2009-12","conditions":"Acute Gout","enrollment":230},{"nctId":"NCT00235079","phase":"PHASE4","title":"Study of Colchicine to Treat and Prevent Recurrent Pericarditis After Failure of Conventional Treatment.","status":"COMPLETED","sponsor":"Azienda Sanitaria Locale 3, Torino","startDate":"2005-11","conditions":"Pericarditis, Recurrence","enrollment":240},{"nctId":"NCT01005121","phase":"PHASE2","title":"Colchicine for Diabetic Nephropathy","status":"UNKNOWN","sponsor":"Prof.Avi Livneh","startDate":"2009-12","conditions":"Diabetic Nephropathy","enrollment":12},{"nctId":"NCT00128414","phase":"PHASE3","title":"Study of Colchicine to Treat and Prevent Recurrent Pericarditis (First Episode)","status":"COMPLETED","sponsor":"Azienda Sanitaria Locale 3, Torino","startDate":"2005-08","conditions":"Pericarditis, Recurrence","enrollment":120}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":59,"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":"Colchicine (for 6 months)","genericName":"Colchicine (for 6 months)","companyName":"Azienda Sanitaria Locale 3, Torino","companyId":"azienda-sanitaria-locale-3-torino","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Colchicine is being studied for its potential effects on various conditions, including Acute Gout, Inflammation, and Aortic Stenosis, among others. Clinical trials have investigated Colchicine's efficacy in comparison to Placebo and other interventions, such as Canakinumab, in treating these conditions.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}