Oral prednisolone (DrugBank: Prednisolone)
40 diseases告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
11 | 重症筋無力症 | 0 |
13 | 多発性硬化症/視神経脊髄炎 | 0 |
14 | 慢性炎症性脱髄性多発神経炎/多巣性運動ニューロパチー | 0 |
25 | 進行性多巣性白質脳症 | 0 |
26 | HTLV-1関連脊髄症 | 0 |
35 | 天疱瘡 | 0 |
38 | スティーヴンス・ジョンソン症候群 | 0 |
39 | 中毒性表皮壊死症 | 0 |
40 | 高安動脈炎 | 0 |
41 | 巨細胞性動脈炎 | 0 |
43 | 顕微鏡的多発血管炎 | 0 |
44 | 多発血管炎性肉芽腫症 | 0 |
45 | 好酸球性多発血管炎性肉芽腫症 | 0 |
46 | 悪性関節リウマチ | 3 |
49 | 全身性エリテマトーデス | 2 |
50 | 皮膚筋炎/多発性筋炎 | 4 |
51 | 全身性強皮症 | 2 |
56 | ベーチェット病 | 0 |
60 | 再生不良性貧血 | 0 |
61 | 自己免疫性溶血性貧血 | 0 |
63 | 特発性血小板減少性紫斑病 | 0 |
64 | 血栓性血小板減少性紫斑病 | 0 |
65 | 原発性免疫不全症候群 | 0 |
66 | IgA腎症 | 1 |
75 | クッシング病 | 0 |
81 | 先天性副腎皮質酵素欠損症 | 0 |
84 | サルコイドーシス | 0 |
85 | 特発性間質性肺炎 | 0 |
95 | 自己免疫性肝炎 | 0 |
96 | クローン病 | 0 |
97 | 潰瘍性大腸炎 | 0 |
113 | 筋ジストロフィー | 0 |
145 | ウエスト症候群 | 2 |
162 | 類天疱瘡(後天性表皮水疱症を含む。) | 0 |
222 | 一次性ネフローゼ症候群 | 0 |
269 | 化膿性無菌性関節炎・壊疽性膿皮症・アクネ症候群 | 0 |
271 | 強直性脊椎炎 | 0 |
296 | 胆道閉鎖症 | 0 |
299 | 嚢胞性線維症 | 0 |
300 | IgG4関連疾患 | 0 |
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 | NCT01395251 (ClinicalTrials.gov) | February 2012 | 12/7/2011 | Diagnostic Value of Oral Prednisolone Test for Rheumatoid Arthritis | Phase II/III Study of Oral Prednisolone Test in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Prednisolone | Rheumazentrum Ruhrgebiet | NULL | Completed | 18 Years | N/A | Both | 130 | Phase 2;Phase 3 | Germany |
2 | EUCTR2011-002633-19-DE (EUCTR) | 21/12/2011 | 02/08/2011 | Prednisolone test for patients with an inflammatory joint disease | Diagnostic value of oral prednisolone test for rheumatoid arthritis - RZR12011-TryCort | rheumatoid arthritis MedDRA version: 14.0;Level: LLT;Classification code 10062719;Term: Seronegative rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE Product Name: Paracetamol INN or Proposed INN: PARACETAMOL | Rheumazentrum Ruhrgebiet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany | ||||
3 | EUCTR2007-006729-28-GB (EUCTR) | 25/01/2008 | 04/12/2007 | Is a single dose intramuscular (IM) triamcinolone acetonide injection more effective in treating symptomatic flare in established rheumatoid arthritis than equivalent dose of oral prednisolone? - Treatment comparison for symptomatic flare in RA | Is a single dose intramuscular (IM) triamcinolone acetonide injection more effective in treating symptomatic flare in established rheumatoid arthritis than equivalent dose of oral prednisolone? - Treatment comparison for symptomatic flare in RA | The objective of this study is to compare the efficacy of equivalent doses of IM triamcinolone acetonide and oral prednisolone in controlling a symptomatic flare in patients with established RA. MedDRA version: 9.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up | Trade Name: Kenalog Product Name: Triamcinolone acetonide INN or Proposed INN: TRIAMCINOLONE ACETONIDE Trade Name: Prednisolone Product Name: Prednisolone INN or Proposed INN: PREDNISOLONE | Trafford NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 58 | United Kingdom |
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 | NCT01773616 (ClinicalTrials.gov) | April 2015 | 1/11/2012 | Trial of Rituximab and Mycophenolate Mofetil Without Oral Steroids for Lupus Nephritis | Phase 3 Open Label Randomised Multicentre Controlled Trial of Rituxmab and Mycophenolate Mofetil Without Oral Steroids for the Treatment of Lupus Nephritis | Systemic Lupus Erythematosus, Lupus Nephritis | Drug: Oral prednisolone;Drug: Rituximab;Drug: Mycophenolate mofetil;Drug: Methyl prednisolone | Imperial College London | Karolinska Institutet;Ohio State University;Dutch Working Party on Systemic Lupus Erythematosus;EULAR Lupus Nephritis Trial Network Study Group | Terminated | 12 Years | 75 Years | All | 24 | Phase 3 | United Kingdom |
2 | JPRN-UMIN000000639 | 2007/03/01 | 16/03/2007 | A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III study of Rituximab in Patients with Systemic Lupus Erythematosus | Systemic lupus erythematosus | IDEC-C2B8 plus oral prednisolone(tapering) 1000 mg of IDEC-C2B8 on days 1 and 15.Repeated at an interval of 6 months (Days 169 and 183). Placebo plus oral prednisolone(tapering) 1000 mg of placebo day 1 and 15.Repeated at an interval of 6 months (Days 169 and 183). | Zenyaku Kogyo Co., Ltd. | NULL | Complete: follow-up complete | 16years-old | 75years-old | Male and Female | 150 | Phase 2;Phase 3 | 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 |
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1 | JPRN-UMIN000032193 | 2018/04/11 | 13/04/2018 | Efficacy and safety of combination therapy of corticosteroid and tacrolimus for patients with anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis-associated interstitial lung disease: a prospective multicenter clinical trial | Efficacy and safety of combination therapy of corticosteroid and tacrolimus for patients with anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis-associated interstitial lung disease: a prospective multicenter clinical trial - Combination therapy of corticosteroid and tacrolimus for anti-MDA5 antibody-positive DM-ILD | anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis (DM)/clinically amyopathic dermatomyositis (CADM)-associated interstitial lung disease | Patients without poor prognostic factors: combination therapy of corticosteroid (prednisolone) and tacrolimus for 12 months Initial dose of oral prednisolone is 0.7 - 1mg/kg/day (Maximum dose of prednisolone is 60mg/body/day). Intravenous methylprednisolone pulse therapy (0.5 - 1g/day for 3 days) is permitted according to the initial disease activity. After 4 weeks of initial treatment, prednisolone is tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more in the study period (12 months). Tacrolimus is administered orally at initial dose of 0.075 mg/kg/day (twice daily) and adjusted over time to maintain a whole-blood trough level of 5 - 10 ng/ml. For patients with poor prognostic factors, attending physician can chose any treatments (e.g. corticosteroid, immunosuppressant, IVIG). The patients were followed up for 12 months. | Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine | NULL | Recruiting | 20years-old | 80years-old | Male and Female | 40 | Not selected | Japan |
2 | JPRN-UMIN000032022 | 2018/04/01 | 01/04/2018 | Efficacy and safety of corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for patients with anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis-associated interstitial lung disease: a prospective randomized multicenter clinical trial | Efficacy and safety of corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for patients with anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis-associated interstitial lung disease: a prospective randomized multicenter clinical trial - Corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for anti-ARS antibody-positive PM/DM-ILD | anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated interstitial lung disease | Arm 1: corticosteroid (prednisolone) monotherapy for 24 months Initial dose of oral prednisolone is 0.7 - 1mg/kg/day. (Maximum dose of prednisolone is 60mg/body/day.) Intravenous methylprednisolone pulse therapy (0.5 - 1g/day for 3 days) is permitted according to the initial disease activity. After 4 weeks of initial treatment, prednisolone is tapered by approximately 10 to 20% every 2 to 4 weeks (from 1 to 9 month) and continued at dose of 0.125 - 0.15 mg/kg/day or more (from 9 to 12 month) or 0.1 - 0.125 mg/kg/day or more (from 12 to 24 month). Arm 2: combination therapy of corticosteroid (prednisolone) and tacrolimus for 24 months Initial dose of oral prednisolone is 0.7 - 1mg/kg/day. (Maximum dose of prednisolone is 60mg/body/day.) Intravenous methylprednisolone pulse therapy (0.5 - 1g/day for 3 days) is permitted according to the initial disease activity. After 4 weeks of initial treatment, prednisolone is tapered by approximately 10 to 20% every 2 to 4 weeks (from 1 to 9 month) and continued at dose of 0.125 - 0.15 mg/kg/day or more (from 9 to 12 month) or 0.1 - 0.125 mg/kg/day or more (from 12 to 24 month). Tacrolimus is administered orally at initial dose of 0.075 mg/kg/day (twice daily) and adjusted over time to maintain a whole-blood trough level of 5 - 10 ng/ml. | Hamamatsu University School of Medicine | NULL | Recruiting | 20years-old | 80years-old | Male and Female | 66 | Not selected | Japan |
3 | JPRN-UMIN000015469 | 2014/10/20 | 18/10/2014 | Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease | Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease - Comparison between tacrolimus and cyclosporine for the treatment of PM/DM-ILD | polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated Interstitial lung disease | arm1: tacrolimus and predonisolon therapy for 52 weeks Initial dose of oral prednisolone is 0.6 - 1 mg/kg/day. Intravenous methylprednisolone pulse therapy (1 g/day for 3 days) is permitted according to the disease activity. After 4 weeks of initial treatment, prednisolone was tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more. Taclorimus is administered orally at initial dose of 0.075 mg/kg/day (twice daily) and adjusted over time to maintain a whole-blood trough level of 5 - 10 ng/ml. arm2: cyclosporine and predonisolone therapy for 52 weeks Initial dose of oral prednisolone is 0.6 - 1 mg/kg/day. Intravenous methylprednisolone pulse therapy (1 g/day for 3 days) is permitted according to the disease activity. After 4 weeks of initial treatment, prednisolone was tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more. Cyclosporine is administered orally at initial dose of 3 mg/kg/day (twice daily before meal) and adjusted over time to maintain a whole-blood trough level of 100 - 150 ng/ml. | Second Division, Department of Internal medicine, Hamamatsu University School of Medicine | NULL | Complete: follow-up complete | 18years-old | 75years-old | Male and Female | 50 | Not selected | Japan |
4 | JPRN-UMIN000001866 | 2009/04/01 | 10/04/2009 | Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis | Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis - Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis | Dermatomyositis or polymyositis with interstitial pneumonia | (1)The patients are initially treated with methylprednisolone (m-PSL) pulse (1000 mg daily for three days) followed by oral prednisolone (1mg/kg daily). (2)Continuous intravenous CyA (2 mg/kg daily for initial dose) is started following m-PSL pulse therapy, and the dosage will be adjusted to a level of 200-300ng/ml. | Department of Neurology and Rheumatology, Shinshu University School of Medicine | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 10 | Not selected | 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 | NCT03708718 (ClinicalTrials.gov) | December 21, 2017 | 8/10/2018 | Prednisolone in Early Diffuse Systemic Sclerosis | A Phase II Randomised Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis (Initially Double-blind, Then Switched to Open-label Because of Covid-19) | Systemic Sclerosis | Drug: Prednisolone 5 mg;Drug: Placebo oral capsule; From August 2020 'no additional treatment' | Prof. Ariane herrick | Versus Arthritis | Recruiting | 18 Years | N/A | All | 72 | Phase 2 | United Kingdom |
2 | EUCTR2016-002651-25-GB (EUCTR) | 11/07/2017 | 08/05/2018 | A Study of Prednisolone in Patients with Early (within 3 years of onset) Diffuse Cutaneous Scleroderma (Systemic Sclerosis) | A Phase II Randomised Controlled Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis - PRedSS: Prednisolone in Early Diffuse Systemic Sclerosis. Version 1.0 | Early diffuse cutaneous systemic sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Prednisolone 5mg Gastro-resistant Tablets Product Name: Prednisolone 5mg Gastro-resistant Tablets INN or Proposed INN: Prednisolone Other descriptive name: Prednisolon;Prednisolona; Prednisoloni; Prednisolonum; Prednizolon;Prednizolonas | Research Governance and Integrity, University of Manchester | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United Kingdom |
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-UMIN000000593 | 2006/11/01 | 05/02/2007 | Randomized controlled trial of mizoribine for progressive IgA nephropathy | IgA nephropathy with moderate to severe histological alterations | Methylprednisolone pulse therapy followed by oral prednisolone administration Methylprednisolone pulse therapy followed by oral prednisolone and mizoribine administration | West Japan Study Group for Therapy of IgA Nephropathy | NULL | Complete: follow-up complete | 15years-old | 60years-old | Male and Female | 120 | Not selected | 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 | NCT03876444 (ClinicalTrials.gov) | April 1, 2019 | 12/3/2019 | Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms | Intravenous Methylprednisolone Versus High Dose Oral Prednisolone for the Treatment of Infantile Spasms: a Randomized Open-labelled Trial | Infantile Spasm | Drug: Intravenous Methylprednisolone;Drug: Oral Pednisolone | Suvasini Sharma | NULL | Recruiting | 4 Months | 30 Months | All | 128 | Phase 2;Phase 3 | India |
2 | NCT01575639 (ClinicalTrials.gov) | February 2012 | 9/4/2012 | Prednisolone in Infantile Spasms- High Dose Versus Usual Dose | Randomized Trial of High Dose (4mg/kg) Versus Usual Dose (2mg/kg) Oral Prednisolone in the Treatment of Infantile Spasms. | Infantile Spasms;West Syndrome | Drug: Oral prednisolone | Lady Hardinge Medical College | NULL | Completed | 3 Months | 24 Months | Both | 63 | Phase 3 | India |