97. Ulcerative colitis Clinical trials / Disease details
Clinical trials : 2,630 / Drugs : 1,459 - (DrugBank : 265) / Drug target genes : 144 - Drug target pathways : 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 | EUCTR2013-001744-65-BE (EUCTR) | 23/01/2018 | 27/02/2017 | A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases | Mild to Moderate Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden | ||
| 2 | EUCTR2013-001744-65-DE (EUCTR) | 10/01/2018 | 20/02/2017 | A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases | Mild to Moderate Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden | ||
| 3 | EUCTR2013-001744-65-PL (EUCTR) | 20/10/2014 | 19/08/2014 | A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases | Mild to Moderate Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine | Shire Devlopment LLC | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Hungary;Slovakia;Canada;Belgium;Poland;Israel;Netherlands;Germany;United Kingdom;Sweden | ||
| 4 | EUCTR2013-001744-65-SK (EUCTR) | 11/09/2014 | 17/07/2014 | A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases | Mild to Moderate Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine | Shire Devlopment LLC | NULL | Not Recruiting | Female: yes Male: yes | 132 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden |