96. クローン病 Crohn disease Clinical trials / Disease details
臨床試験数 : 2,400 / 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
| 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 | EUCTR2017-002258-36-NL (EUCTR) | 25/05/2018 | 17/10/2017 | Phase II clinical trial, conducted in different sites, with random assignation of treatment, where neither the patient or the medical doctor know the assigned treatment, drug or placebo, to evaluate the efficacy and safety of Rifaximin delayed release 400 mg tablet in the prevention of post-operative endoscopic Crohn’sdisease recurrence | A Phase II, multicentre, double-blind, randomised, placebo-controlled study of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn’s disease recurrence - STOP-Postoperative Endoscopic Recurrence Study (STOP-PER) | Post-operative endoscopic Crohn’s disease recurrence MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin delayed release 400 mg film coated tablet Product Code: Rifaximin-EIR INN or Proposed INN: RIFAXIMIN Other descriptive name: RIFAXIMINA | ALFASIGMA S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Spain;Belgium;Germany;Netherlands;Italy | ||
| 2 | EUCTR2017-002258-36-BE (EUCTR) | 05/02/2018 | 02/10/2017 | Phase II clinical trial, conducted in different sites, with random assignation of treatment, where neither the patient or the medical doctor know the assigned treatment, drug or placebo, to evaluate the efficacy and safety of Rifaximin delayed release 400 mg tablet in the prevention of post-operative endoscopic Crohn’s disease recurrence | A Phase II, multicentre, double-blind, randomised, placebo-controlled study of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn’s disease recurrence - STOP-Postoperative Endoscopic Recurrence Study (STOP-PER) | Post-operative endoscopic Crohn’s disease recurrence MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin delayed release 400 mg film coated tablet Product Code: Rifaximin-EIR INN or Proposed INN: RIFAXIMIN Other descriptive name: RIFAXIMINA | ALFASIGMA S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Belgium;Netherlands;Germany | ||
| 3 | EUCTR2017-002258-36-ES (EUCTR) | 04/12/2017 | 03/10/2017 | Phase II clinical trial, conducted in different sites, with random assignation of treatment, where neither the patient or the medical doctor know the assigned treatment, drug or placebo, to evaluate the efficacy and safety of Rifaximin delayed release 400 mg tablet in the prevention of post-operative endoscopic Crohn’sdisease recurrence | A Phase II, multicentre, double-blind, randomised, placebo-controlled study of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn’s disease recurrence - STOP-Postoperative Endoscopic Recurrence Study (STOP-PER) | Post-operative endoscopic Crohn’s disease recurrence MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin delayed release 400 mg film coated tablet Product Code: Rifaximin-EIR INN or Proposed INN: RIFAXIMIN Other descriptive name: RIFAXIMINA | ALFASIGMA S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Spain;Germany | ||
| 4 | EUCTR2017-002258-36-DE (EUCTR) | 21/11/2017 | 01/08/2017 | Phase II clinical trial, conducted in different sites, with random assignation of treatment, where neither the patient or the medical doctor know the assigned treatment, drug or placebo, to evaluate the efficacy and safety of Rifaximin delayed release 400 mg tablet in the prevention of post-operative endoscopic Crohn’s disease recurrence | A Phase II, multicentre, double-blind, randomised, placebo-controlled study of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn’s disease recurrence - STOP-Postoperative Endoscopic Recurrence Study (STOP-PER) | Post-operative endoscopic Crohn’s disease recurrence MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin delayed release 400 mg film coated tablet Product Code: Rifaximin-EIR INN or Proposed INN: RIFAXIMIN Other descriptive name: RIFAXIMINA | ALFASIGMA S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Belgium;Netherlands;Germany | ||
| 5 | EUCTR2011-002821-24-IT (EUCTR) | 21/07/2011 | 27/02/2012 | Study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets. | Prospective pharmacodynamic study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets. - RETIC-PD/006/2011 | Treatment of active, moderate Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin-EIR Product Code: NA INN or Proposed INN: RIFAXIMIN Other descriptive name: NA | ALFA WASSERMANN | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 6 | EUCTR2007-001014-17-DE (EUCTR) | 07/01/2008 | 03/03/2008 | A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease | A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease | Treatment of moderate, active Crohn’s disease: induction of remission. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Rifaximin-EIR | Alfa Wassermann S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 424 | Phase 2 | France;Hungary;Germany;Italy | ||
| 7 | EUCTR2007-001014-17-HU (EUCTR) | 16/10/2007 | 19/06/2007 | A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease | A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease | Treatment of moderate, active Crohn’s disease: induction of remission. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Rifaximin-EIR INN or Proposed INN: Rifaximin | Alfa Wassermann S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 424 | Phase 2 | France;Hungary;Germany;Italy | ||
| 8 | NCT00528073 (ClinicalTrials.gov) | September 2007 | 10/9/2007 | Placebo Controlled Study of 3 Doses of Rifaximin-EIR Tablet to Treat Moderate, Active Crohn's Disease | A Phase II, Multicentre, Double-blind, Randomised, Dose Range Finding Placebo Controlled Study of Rifaximin-EIR Tablet: Clinical Effectiveness and Tolerability in the Treatment of Moderate, Active Crohn's Disease | Crohn's Disease | Drug: Rifaximin-EIR | Alfa Wassermann S.p.A. | NULL | Completed | 18 Years | 75 Years | Both | 410 | Phase 2 | France;Germany;Hungary;Israel;Italy;Poland;Russian Federation |
| 9 | EUCTR2007-001014-17-FR (EUCTR) | 26/07/2007 | 01/06/2007 | A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease | A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease | Treatment of moderate, active Crohn’s disease: induction of remission. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Rifaximin-EIR | Alfa Wassermann S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 424 | Phase 2 | France;Hungary;Germany;Italy |