97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| 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 | NCT04882683 (ClinicalTrials.gov) | June 1, 2021 | 6/5/2021 | Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis | Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis | Ulcerative Colitis | Drug: Prednisone;Drug: Azathioprine;Drug: Adalimumab;Biological: umbilical cord blood mononuclear cells | Shandong Qilu Stem Cells Engineering Co., Ltd. | NULL | Recruiting | 18 Years | 65 Years | All | 50 | N/A | China |
| 2 | EUCTR2020-003420-16-IT (EUCTR) | 29/01/2021 | 02/08/2021 | A study comparing two different therapeutic approaches in the treatment of moderate to severe ulcerative colitis. | SPRINT_”AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE STEP-UP VS TOP-DOWN TREATMENT ALGORITHMS IN MODERATE TO SEVERE ULCERATIVE COLITIS.” - SPRINT | Moderate to severe ulcerative colitis. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Amgevita Product Name: Adalimumab Product Code: [n.d.] INN or Proposed INN: ADALIMUMAB Product Name: Azatioprina Product Code: [n.d.] INN or Proposed INN: AZATIOPRINA Product Name: Prednisone Product Code: [n.d.] INN or Proposed INN: PREDNISONE INN or Proposed INN: PREDNISONE | IRCCS ISTITUTO CLINICO HUMANITAS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 4 | Portugal;France;Spain;Belgium;Austria;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 3 | NCT02921555 (ClinicalTrials.gov) | October 11, 2018 | 22/9/2016 | Endovenous Corticosteroid Pulses in Moderate Ulcerative Colitis | Efficacy of High-dose Corticosteroid Pulses Added to Conventional Oral Corticosteroid Course for Moderate Flares of Ulcerative Colitis. | Ulcerative Colitis | Drug: Methylprednisolone;Drug: Prednisone | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa | NULL | Completed | 18 Years | N/A | All | 75 | Phase 4 | Spain |
| 4 | NCT02910245 (ClinicalTrials.gov) | November 2016 | 9/9/2016 | Mercaptopurine Therapy in Ulcerative Colitis | Efficacy of Optimized Thiopurine Therapy in Ulcerative Colitis (OPTIC) | Colitis, Ulcerative | Drug: Mercaptopurine (Purinethol);Drug: Placebo;Drug: Mesalamine;Drug: Prednisone | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | ZonMw: The Netherlands Organisation for Health Research and Development | Recruiting | 18 Years | 80 Years | All | 136 | Phase 3 | Netherlands |
| 5 | ChiCTR-ICR-15007188 | 2015-10-09 | 2015-10-09 | Percutaneous endoscopic mini-colostomy anddrug delivery system for the treatment of ulcerative colitis: A randomized, controlled clinical trial | Percutaneous endoscopic mini-colostomy anddrug delivery system for the treatment of ulcerative colitis: A randomized, controlled clinical trial | Ulcerative colitis | Percutaneous endoscopic mini-colostomy group:Oral steroids (prednisone 1mg.kg-1d-1) +Percutaneous endoscopic mini-colostomy andsubsequent drug delivery (mesalazine 3g / d);Control Group:Oral steroids (prednisone 1mg.kg-1d-1) andmesalazine 3g / d; | Southern Medical University, Nanfang Hospital, Department of Gastroenterology | NULL | Recruiting | Both | Percutaneous endoscopic mini-colostomy group:21;Control Group:21; | China | |||
| 6 | EUCTR2007-003815-30-PT (EUCTR) | 31/07/2009 | 05/03/2009 | An Open Randomized Multicenter Clinical Investigation to Compare the Efficacy and Safety of Prednisone plus Adacolumn® GMA Apheresis versus Prednisone Alone in the Treatment of Patients with Mild or Moderately Active Steroid Dependent Ulcerative Colitis | An Open Randomized Multicenter Clinical Investigation to Compare the Efficacy and Safety of Prednisone plus Adacolumn® GMA Apheresis versus Prednisone Alone in the Treatment of Patients with Mild or Moderately Active Steroid Dependent Ulcerative Colitis | Mild or Moderately Active Steroid Dependent Ulcerative Colitis MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Dacortin Product Name: prednisone INN or Proposed INN: Prednisone INN or Proposed INN: Prednisone Trade Name: Dacortin Product Name: prednisone Product Code: H02AB INN or Proposed INN: PREDNISONE INN or Proposed INN: PREDNISONE | GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa) | NULL | Not Recruiting | Female: yes Male: yes | Portugal;Spain | ||||
| 7 | EUCTR2006-004230-32-BE (EUCTR) | 21/12/2007 | 04/12/2007 | Efficacy and safety of Beclomethasone dipropionate, gastro-resistant, prolonged release tablets (CHF1514) compared to oral prednisone, in a 8-week treatment period, in patients with active ulcerative colitis. An international, multicentre, randomized, double blind, parallel group study. - Beta study | Efficacy and safety of Beclomethasone dipropionate, gastro-resistant, prolonged release tablets (CHF1514) compared to oral prednisone, in a 8-week treatment period, in patients with active ulcerative colitis. An international, multicentre, randomized, double blind, parallel group study. - Beta study | Ulcerative colitis extending proximally beyond the rectum. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Clipper 30 cpr 5mg R.M. INN or Proposed INN: BECLOMETASONE DIPROPIONATE Trade Name: Deltacortene 20 cpr 5mg INN or Proposed INN: PREDNISONE Trade Name: Deltacortene 10 cpr 25mg INN or Proposed INN: PREDNISONE | CHIESI Farmaceutici S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Belgium;Spain;Italy;Poland | |||
| 8 | EUCTR2006-004230-32-PL (EUCTR) | 07/12/2007 | 05/09/2007 | EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS. AN INTERNATIONAL, MUTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP STUDY - Beta study | EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS. AN INTERNATIONAL, MUTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP STUDY - Beta study | Ulcerative Colitis extending proximally beyond the rectum with bleeding, verified by endoscopic examination MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Clipper INN or Proposed INN: Beclomethasone diproprionate Trade Name: Deltacortene INN or Proposed INN: Prednisone Trade Name: Deltacortene INN or Proposed INN: Prednisone | Chiesi Farmaceutici SpA | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Belgium;Spain;Poland;Italy | ||
| 9 | EUCTR2007-003815-30-ES (EUCTR) | 27/11/2007 | 24/10/2007 | Estudio abierto, randomizado, multicéntrico para comparar la eficacia y la seguridad de la prednisona y granulocitoféresis con Adacolumn® versus la prednisona sola en el tratamiento de pacientes con colitis ulcerosa activa corticodependiente leve a moderada. | Estudio abierto, randomizado, multicéntrico para comparar la eficacia y la seguridad de la prednisona y granulocitoféresis con Adacolumn® versus la prednisona sola en el tratamiento de pacientes con colitis ulcerosa activa corticodependiente leve a moderada. | Colitis ulcerosa corticodependiente leve o moderada MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: DACORTIN Product Name: PREDNISONE INN or Proposed INN: PREDNISONE Other descriptive name: N/A | GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa) | NULL | Not Recruiting | Female: yes Male: yes | Portugal;Spain | ||||
| 10 | EUCTR2006-004230-32-ES (EUCTR) | 22/08/2007 | 26/09/2007 | EFICACIA Y SEGURIDAD DE COMPRIMIDOS DE BECLOMETASONA DIPROPIONATO (CHF1514) GASTRORRESISTENTES DE LIBERACIÓN PROLONGADA, FRENTE A PREDNISONA ORAL, DURANTE UN PERIODO DE TRATAMIENTO DE 8 SEMANAS EN PACIENTES CON COLITIS ULCEROSA ACTIVA. ESTUDIO INTERNACIONAL, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO DE GRUPOS PARALELOS. - Estudio BETA | EFICACIA Y SEGURIDAD DE COMPRIMIDOS DE BECLOMETASONA DIPROPIONATO (CHF1514) GASTRORRESISTENTES DE LIBERACIÓN PROLONGADA, FRENTE A PREDNISONA ORAL, DURANTE UN PERIODO DE TRATAMIENTO DE 8 SEMANAS EN PACIENTES CON COLITIS ULCEROSA ACTIVA. ESTUDIO INTERNACIONAL, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO DE GRUPOS PARALELOS. - Estudio BETA | Colitis ulcerosa activa, extendiéndose en sentido proximal más allá del recto. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Clipper INN or Proposed INN: BECLOMETASONE DIPROPIONATE Trade Name: Deltacortene INN or Proposed INN: PREDNISONE Trade Name: Deltacortene INN or Proposed INN: PREDNISONE | Chiesi Farmaceutici SpA | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Belgium;Poland;Spain;Italy | ||
| 11 | EUCTR2006-004230-32-IT (EUCTR) | 06/06/2007 | 12/11/2007 | Efficacy and safety of beclometasone dipropionate (BDP) gastro-resistant prolonged release tablets (CHF1514) compared to oral steroid (prednisone) in an 8-week treatment period in patients with active moderate ulcerative colitis. A multicentre, randomised, controlled, double blind, parallel group study. Beta study - BETA | Efficacy and safety of beclometasone dipropionate (BDP) gastro-resistant prolonged release tablets (CHF1514) compared to oral steroid (prednisone) in an 8-week treatment period in patients with active moderate ulcerative colitis. A multicentre, randomised, controlled, double blind, parallel group study. Beta study - BETA | Mild moderate active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: CLIPPER*30CPR 5MG R.M. INN or Proposed INN: Beclometasone Trade Name: DELTACORTENE*20CPR 5MG INN or Proposed INN: Prednisone Trade Name: DELTACORTENE FORTE*10CPR 25MG INN or Proposed INN: Prednisone | CHIESI | NULL | Not Recruiting | Female: yes Male: yes | 300 | Belgium;Spain;Italy;Poland |