Mezavant XL Gastro-resistant, prolonged release tablets ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 97 | 潰瘍性大腸炎 | 11 |
97. 潰瘍性大腸炎
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 | EUCTR2013-001744-65-NL (EUCTR) | 02/03/2015 | 07/08/2014 | 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: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant XL 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 | 128 | 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;Belgium;Poland;Israel;Germany;Netherlands;United Kingdom | ||
| 2 | EUCTR2013-001744-65-GB (EUCTR) | 22/10/2014 | 31/03/2014 | 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 XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL 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 | 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 | ||
| 3 | EUCTR2013-001744-65-HU (EUCTR) | 24/09/2014 | 15/07/2014 | 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 XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL 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;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom | ||
| 4 | EUCTR2009-017044-13-DE (EUCTR) | 03/11/2010 | 16/06/2010 | A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis | A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM | Ulcerative Colitis MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development Inc | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany | ||
| 5 | EUCTR2009-017044-13-BE (EUCTR) | 14/09/2010 | 06/05/2010 | A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis | A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Belgium;Poland;South Africa;Germany | ||
| 6 | EUCTR2009-017044-13-IE (EUCTR) | 10/08/2010 | 20/04/2010 | A study to Evaluate the Ability to Maintain Clinical andEndoscopic Remission During a 12-Month period with 2.4g/day of druggiven once a day in adults with ulcerative colitis | A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany | ||
| 7 | EUCTR2009-017044-13-CZ (EUCTR) | 05/08/2010 | 28/05/2010 | A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis | A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Hungary;Canada;Poland;South Africa;Germany;United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Czech Republic | ||
| 8 | EUCTR2009-017044-13-FR (EUCTR) | 27/07/2010 | 22/06/2010 | A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis | A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development Inc | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | France;Czech Republic;Hungary;Belgium;Spain;Ireland;Germany;United Kingdom | ||
| 9 | EUCTR2009-017044-13-HU (EUCTR) | 21/07/2010 | 26/04/2010 | A Study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis | A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany | ||
| 10 | EUCTR2009-017044-13-GB (EUCTR) | 30/06/2010 | 17/03/2010 | A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis | A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/day MMX® Mesalamine/mesalazine Once Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Belgium;South Africa;Germany | ||
| 11 | EUCTR2009-017044-13-ES (EUCTR) | 25/06/2010 | 19/04/2010 | Estudio en fase 3b/4, abierto, multicéntrico y prospectivo para evaluar el efecto del estado de la remisión sobre la capacidad para mantener o alcanzar la remisión clínica y endoscópica durante una fase de mantenimiento a largo plazo de 12 meses con 2,4 g/día de MMX mesalamina/mesalazina una vez al día en pacientes adultos con colitis ulcerosaA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis | Estudio en fase 3b/4, abierto, multicéntrico y prospectivo para evaluar el efecto del estado de la remisión sobre la capacidad para mantener o alcanzar la remisión clínica y endoscópica durante una fase de mantenimiento a largo plazo de 12 meses con 2,4 g/día de MMX mesalamina/mesalazina una vez al día en pacientes adultos con colitis ulcerosaA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis | Colitis UlcerosaUlcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | France;Czech Republic;Hungary;Belgium;Spain;Ireland;Germany;United Kingdom |