97. Ulcerative colitis Clinical trials / Disease details
Clinical trials : 2,527 / Drugs : 1,465 - (DrugBank : 259) / 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-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 | ||
| 4 | NCT02093663 (ClinicalTrials.gov) | December 12, 2014 | 17/3/2014 | Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis, in Both Acute and Maintenance Phases | Ulcerative Colitis | Drug: MMX Mesalamine/Mesalazine (Low Dose);Drug: MMX Mesalamine/Mesalazine (High Dose) | Shire | NULL | Completed | 5 Years | 17 Years | All | 107 | Phase 3 | United States;Canada;Hungary;Israel;Poland;Slovakia;United Kingdom;Belgium;Germany;Netherlands |
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | EUCTR2011-000164-10-GB (EUCTR) | 04/01/2013 | 19/09/2012 | Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis | A Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis | 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] | Product Code: SPD476 INN or Proposed INN: mesalazine Product Code: SPD476 INN or Proposed INN: mesalazine Trade Name: Mezavant XL 1200mg gastro-resistant, prolonged release tablets Product Code: SPD476 INN or Proposed INN: mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 1 | United States;Slovakia;Poland;Australia;United Kingdom | ||
| 10 | EUCTR2011-000164-10-SK (EUCTR) | 21/06/2012 | 13/04/2016 | Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis | A Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis | 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] | Product Name: SPD476 Product Code: SPD476 INN or Proposed INN: mesalazine Product Name: SPD476 Product Code: SPD476 INN or Proposed INN: mesalazine Product Name: SPD476 Product Code: SPD476 INN or Proposed INN: mesalazine | Shire Development Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 1 | United States;Slovakia;United Kingdom | ||
| 11 | 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 | ||
| 12 | NCT01130844 (ClinicalTrials.gov) | October 8, 2010 | 20/5/2010 | Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis | A Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis | Ulcerative Colitis | Drug: MMX Mesalamine | Shire | NULL | Completed | 5 Years | 17 Years | All | 52 | Phase 1 | United States;Australia;Poland;Slovakia;United Kingdom |
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | NCT01124149 (ClinicalTrials.gov) | June 29, 2010 | 13/5/2010 | Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis | A Phase 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 | Ulcerative Colitis | Drug: MMX mesalamine/ mesalazine | Shire | NULL | Completed | 18 Years | N/A | All | 759 | Phase 4 | United States;Belgium;Canada;Colombia;Czechia;France;Germany;Hungary;India;Ireland;Poland;Romania;South Africa;Spain;United Kingdom;Brazil;Czech Republic |
| 20 | 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 | ||
| 21 | NCT00446849 (ClinicalTrials.gov) | May 1, 2007 | 12/3/2007 | Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC) | A Phase IV, Multi-center, Open-label Study to Assess Clinical Recurrence Related to Compliance With Treatment With MMX Mesalamine 2.4g/Day Given Once Daily for the Maintenance of Quiescent Ulcerative Colitis (UC) | Ulcerative Colitis | Drug: MMX Mesalamine | Shire | NULL | Completed | 18 Years | N/A | All | 290 | Phase 4 | United States |