Colchicine (DrugBank: Colchicine)
7 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 2 | 筋萎縮性側索硬化症 | 2 |
| 42 | 結節性多発動脈炎 | 1 |
| 46 | 悪性関節リウマチ | 1 |
| 56 | ベーチェット病 | 2 |
| 93 | 原発性胆汁性胆管炎［原発性胆汁性肝硬変 (~2017.3)］ | 1 |
| 210 | 単心室症 | 1 |
| 266 | 家族性地中海熱 | 12 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03693781 (ClinicalTrials.gov) | April 10, 2019 | 30/9/2018 | Colchicine for Amyotrophic Lateral Sclerosis | Colchicine for Amyotrophic Lateral Sclerosis: a Phase II, Randomized, Double Blind, Placebo Controlled, Multicenter Clinical Trial | Amyotrophic Lateral Sclerosis | Drug: Colchicine 1 MG Oral Tablet;Drug: Placebo Oral Tablet | Azienda Ospedaliero-Universitaria di Modena | University of Modena and Reggio Emilia;University of Turin, Italy;Istituto Auxologico Italiano;IRCCS National Neurological Institute C. Mondino Foundation;University of Bari;IRCCS San Raffaele;University of Padova;University of Milan;Istituto Di Ricerche Farmacologiche Mario Negri;University of Campania Luigi Vanvitelli;Catholic University of the Sacred Heart | Recruiting | 18 Years | 80 Years | All | 54 | Phase 2 | Italy |
| 2 | EUCTR2017-004459-21-IT (EUCTR) | 11/09/2018 | 07/11/2018 | Study evaluating the treatment with colchicine for the amyotrophic lateral sclerosis | Colchicine for Amyotrophic Lateral Sclerosis: a phase II, randomized, double blind, placebo controlled, multicenter clinical trial - Co-ALS | Definite or probable amyotrophic lateral sclerosis MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: LLT;Classification code 10052889;Term: ALS;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: COLCHICINA LIRCA - 1 MG COMPRESSE 60 COMPRESSE Product Name: Colchicina Product Code: Colchicina INN or Proposed INN: COLCHICINA Other descriptive name: COLCHICINA | AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 2 | Italy |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02939573 (ClinicalTrials.gov) | January 2017 | 18/10/2016 | A Randomized Multicenter Study for Isolated Skin Vasculitis | A Randomized Multicenter Study for Isolated Skin Vasculitis | Primary Cutaneous Vasculitis;Cutaneous Polyarteritis Nodosa;IgA Vasculitis;Henoch-Schönlein Purpura | Drug: Colchicine;Drug: Dapsone;Drug: Azathioprine | University of Pennsylvania | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);National Center for Advancing Translational Science (NCATS);Office of Rare Diseases (ORD) | Recruiting | 18 Years | N/A | All | 90 | Phase 2 | United States;Canada;Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04056039 (ClinicalTrials.gov) | August 14, 2018 | 21/6/2019 | Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity in Patients With Rheumatoid Arthritis. | Efficacy of Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity as a Biomarker of Myocardial Damage in Patients With Rheumatoid Arthritis With Severe Activity. | Cardiovascular Diseases;Arthritis, Rheumatoid | Drug: Atorvastatin;Drug: Colchicine | Hospital Central Dr. Ignacio Morones Prieto | NULL | Completed | 18 Years | N/A | All | 60 | Phase 2 | Mexico |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03888846 (ClinicalTrials.gov) | March 25, 2019 | 21/3/2019 | Topical Pentoxifylline Gel on Behcet's Disease Oral Ulcers | Clinical Protocol for Administration of Topical Pentoxifylline Gel on Behcet's Disease Oral Ulcers | Behçet Disease Affecting Oral Mucosa | Drug: Pentoxifylline;Drug: Colchicine | Ipekyolu Ilac Ltd. Sti | Istanbul University-Cerrahpasa School of Medicine | Recruiting | 18 Years | N/A | All | 60 | Phase 2 | Turkey |
| 2 | NCT00700297 (ClinicalTrials.gov) | August 2002 | 17/6/2008 | Colchicine Randomized Double-Blind Controlled Crossover Study in Behcet's Disease | A Double Blind Cross Over Clinical Trial to Determine Colchicine Efficacy in Behcet`s Disease | Behcet's Syndrome | Drug: Colchicine;Drug: Placebo | Tehran University of Medical Sciences | NULL | Completed | 14 Years | 60 Years | Both | 169 | Phase 2 | Iran, Islamic Republic of |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00004748 (ClinicalTrials.gov) | November 1989 | 24/2/2000 | Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis | Phase III Randomized, Double-Blind, Placebo-Controlled Study of Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis | Liver Cirrhosis, Biliary | Drug: colchicine;Drug: methotrexate;Drug: ursodiol | National Center for Research Resources (NCRR) | Tufts Medical Center | Completed | N/A | N/A | Both | 90 | Phase 3 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03575572 (ClinicalTrials.gov) | August 29, 2018 | 18/6/2018 | Colchicine in Postoperative Fontan Patients | Colchicine in Postoperative Fontan Patients (CPFP) | Single-ventricle;Heart Diseases | Drug: Colchicine | University of Michigan | NULL | Recruiting | 20 Months | 5 Years | All | 25 | Phase 2;Phase 3 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-UMIN000032557 | 2018/09/01 | 30/05/2018 | An open-label continuation trial of tocilizumab for familial Mediterranean fever with colchicine ineffective or intolerance | An open-label continuation trial of tocilizumab for familial Mediterranean fever with colchicine ineffective or intolerance - An open-label continuation trial of tocilizumab for familial Mediterranean fever | familial Mediterranean fever | Tocilizumab | Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences | NULL | Complete: follow-up continuing | 12years-old | Not applicable | Male and Female | 24 | Not selected | Japan |
| 2 | JPRN-UMIN000028010 | 2018/03/01 | 07/07/2017 | Randomized, double-blind, parallel group comparison trial of Tocilizumab for colchicine-resistant familial Mediterranean fever | Randomized, double-blind, parallel group comparison trial of Tocilizumab for colchicine-resistant familial Mediterranean fever - Clinical trial of Tocilizumab for colchicine-resistant familial Mediterranean fever | familial Mediterranean fever | Tocilizumab Placebo | Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences | NULL | Complete: follow-up complete | 12years-old | Not applicable | Male and Female | 24 | Not selected | Japan |
| 3 | NCT03210610 (ClinicalTrials.gov) | October 19, 2017 | 29/6/2017 | Colchicine Levels in the Serum of FMF (Familial Mediterranean Fever) Patients | Measurement of Colchicine Levels in the Serum of FMF Patients | FMF;Colchicine Resistance;Colchicine Toxicity | Diagnostic Test: colchicine level measurement | Sheba Medical Center | NULL | Unknown status | 18 Years | N/A | All | 80 | Israel | |
| 4 | NCT02175589 (ClinicalTrials.gov) | June 2014 | 24/6/2014 | Controlled Ceasing of Colchicine Therapy in Familial Mediterranean Fever (FMF) Patients With Single MEFV (Mediterranean Fever) Gene Mutation | Controlled Ceasing of Colchicine Therapy in Familial Mediterranean Fever (FMF) Patients With Single MEFV (Mediterranean Fever) Gene Mutation | Familial Mediterranean Fever | Other: Colchicine Cessation | Rambam Health Care Campus | Schneider Children's Hospital | Enrolling by invitation | 2 Years | 18 Years | Both | 80 | Phase 2 | Israel |
| 5 | NCT02021084 (ClinicalTrials.gov) | December 2013 | 29/10/2013 | The Effect of Probiotics on Response to Therapy and on Adverse Effect in Patients Treated With Colchicine for Familial Mediterranean Fever. | Familial Mediterranean Fever (FMF ) | Dietary Supplement: probiotic;Dietary Supplement: Placebo | Rambam Health Care Campus | NULL | Withdrawn | 5 Years | 18 Years | Both | 0 | N/A | NULL | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT01705756 (ClinicalTrials.gov) | November 2012 | 27/9/2012 | Kineret (Anakinra), in Adult Patients With Colchicine-Resistant Familial Mediterranean Fever | A Randomized Placebo-Controlled Study of the Efficacy and Safety of Kineret (Anakinra), in Adult Patients With Colchicine-Resistant Familial Mediterranean Fever | Familial Mediterranean Fever | Drug: Kineret | Sheba Medical Center | NULL | Completed | 18 Years | 65 Years | All | 25 | Phase 3 | Israel |
| 7 | NCT02602028 (ClinicalTrials.gov) | April 2011 | 5/11/2015 | The Comparison of the Efficacy of Once and Twice Daily Colchicine Dosage in Pediatric Patients With FMF | The Comparison of the Efficacy of Once and Twice Daily Colchicine Dosage in Pediatric Patients With Familial Mediterranean Fever: A Randomized Trial | Familial Mediterranean Fever | Drug: colchicine | Gulhane Military Medical Academy | NULL | Completed | 5 Years | 16 Years | Both | 79 | Phase 4 | Turkey |
| 8 | NCT01148797 (ClinicalTrials.gov) | December 2010 | 21/6/2010 | Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF) | A 6 Month Phase 2, Multi-Center, Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Treatment With Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever | Colchicine Resistant/Intolerant Familial Mediterranean Fever | Drug: Canakinumab | Novartis Pharmaceuticals | NULL | Completed | 4 Years | 20 Years | Both | 15 | Phase 2 | Israel |
| 9 | NCT01075906 (ClinicalTrials.gov) | August 2010 | 24/2/2010 | Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients | An Open-label, Parallel-group, Multiple-Dose, Pharmacokinetic and Safety Study of Colchicine Pediatric Formulation in Pediatric and Adult Patients With FMF | Familial Mediterranean Fever | Drug: colchicine sprinkle capsules | Mutual Pharmaceutical Company, Inc. | NULL | Completed | 2 Years | 65 Years | Both | 75 | Phase 1 | United States;Armenia;Israel;Turkey |
| 10 | NCT01088880 (ClinicalTrials.gov) | April 2010 | 16/3/2010 | Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever | An Open-label, Exploratory Study to Establish the Safety and Efficacy of 3 Months Treatment With Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever | Familial Mediterranean Fever | Drug: Canakinumab | Novartis Pharmaceuticals | NULL | Completed | 12 Years | 75 Years | Both | 10 | Phase 2 | Turkey |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2015-003527-57-Outside-EU/EEA (EUCTR) | 14/04/2016 | Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever | An Open-label, Exploratory Study to Establish the Safety and Efficacy of 3 Months Treatment With Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever | Familial Mediterranean Fever MedDRA version: 19.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Ilaris Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Pharmaceuticals | NULL | NA | Female: yes Male: yes | 9 | Turkey | ||||
| 12 | EUCTR2015-003522-13-Outside-EU/EEA (EUCTR) | 14/04/2016 | Evaluate the Safety and Efficacy of Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever (FMF) | A 6 Month Phase 2, Multi-Center, Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Treatment With Canakinumab in Pediatric Patients With Colchicine Intolerant or Colchicine Resistant Familial Mediterranean Fever | Colchicine Resistant/Intolerant Familial Mediterranean Fever MedDRA version: 19.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Ilaris Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Pharmaceuticals | NULL | NA | Female: yes Male: yes | 15 | Phase 2 | Israel |