Rifaximin Delayed Release (DR) ( DrugBank: Rifaximin )
1 disease
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 96 | Crohn disease | 12 |
96. Crohn disease
Clinical trials : 2,400 / Drugs : 1,391 - (DrugBank : 267) / Drug target genes : 170 - Drug target pathways : 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 | EUCTR2014-001645-24-PL (EUCTR) | 29/05/2015 | 06/05/2015 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease 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 (DR) INN or Proposed INN: RIFAXIMIN | Salix Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 660 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany | ||
| 2 | EUCTR2014-001644-38-PL (EUCTR) | 13/03/2015 | 30/12/2014 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease 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 (DR) INN or Proposed INN: RIFAXIMIN | Salix Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 660 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany | ||
| 3 | EUCTR2014-001645-24-DE (EUCTR) | 09/02/2015 | 01/10/2014 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 19.0;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 (DR) INN or Proposed INN: RIFAXIMIN | Salix Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany | ||
| 4 | EUCTR2014-001644-38-DE (EUCTR) | 02/02/2015 | 18/09/2014 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 19.0;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 (DR) INN or Proposed INN: RIFAXIMIN | Salix Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany | ||
| 5 | EUCTR2014-001644-38-CZ (EUCTR) | 09/01/2015 | 19/09/2014 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 19.1;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 (DR) INN or Proposed INN: RIFAXIMIN | Salix Pharmaceuticals, Inc. subsidiary of Valeant Pharmaceuticals International In | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany | ||
| 6 | EUCTR2014-001645-24-CZ (EUCTR) | 09/01/2015 | 30/09/2014 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 19.1;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 (DR) INN or Proposed INN: RIFAXIMIN | Salix Pharmaceuticals, Inc subsidiary of Valeant Pharmaceuticals International Inc | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany | ||
| 7 | EUCTR2014-001644-38-FR (EUCTR) | 08/12/2014 | 22/06/2015 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 18.0;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 (DR) INN or Proposed INN: RIFAXIMIN | Salix Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany | ||
| 8 | EUCTR2014-001645-24-FR (EUCTR) | 18/11/2014 | 22/06/2015 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 18.0;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 (DR) INN or Proposed INN: RIFAXIMIN | Salix Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany | ||
| 9 | EUCTR2014-001644-38-HU (EUCTR) | 18/11/2014 | 17/09/2014 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 17.0;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 (DR) INN or Proposed INN: RIFAXIMIN | Salix Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 660 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Czech Republic;Hungary;Canada;Poland;Russian Federation;Israel;Germany | ||
| 10 | EUCTR2014-001645-24-HU (EUCTR) | 18/11/2014 | 24/09/2014 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 17.0;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 (DR) INN or Proposed INN: RIFAXIMIN | Salix Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 660 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Czech Republic;Hungary;Canada;Poland;Russian Federation;Israel;Germany | ||
| 11 | NCT02240108 (ClinicalTrials.gov) | October 28, 2014 | 11/9/2014 | One Year Study of Rifaximin Delayed Release (DR) in Crohn's Disease | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission With Endoscopic Response at 16 Weeks Followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects With Active Moderate Crohn's Disease | Crohn's Disease | Drug: Rifaximin EIR;Drug: Placebo | Bausch Health Americas, Inc. | Salix Pharmaceuticals, Inc. a division of Bausch Health US, LLC | Terminated | 18 Years | N/A | All | 81 | Phase 3 | United States |
| 12 | NCT02240121 (ClinicalTrials.gov) | August 21, 2014 | 11/9/2014 | One Year Study of Rifaximin Delayed Release (DR) Tablets in Crohn's Disease | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission With Endoscopic Response at 16 Weeks Followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects With Active Moderate Crohn's Disease | Crohn's Disease | Drug: Rifaximin EIR;Drug: Placebo | Bausch Health Americas, Inc. | Salix Pharmaceuticals, Inc. a division of Bausch Health US, LLC | Terminated | 18 Years | N/A | All | 80 | Phase 3 | United States |