MEZAVANT ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
97Ulcerative colitis25

97. Ulcerative colitis


Clinical trials : 2,527 Drugs : 1,465 - (DrugBank : 259) / Drug target genes : 144 - Drug target pathways : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2013-001744-65-BE
(EUCTR)
23/01/201827/02/2017A 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 ColitisA 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 LLCNULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden
2EUCTR2013-001744-65-DE
(EUCTR)
10/01/201820/02/2017A 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 ColitisA 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 LLCNULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden
3EUCTR2013-001744-65-NL
(EUCTR)
02/03/201507/08/2014A 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 ColitisA 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 LLCNULLNot 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): noUnited States;Hungary;Slovakia;Canada;Belgium;Poland;Israel;Germany;Netherlands;United Kingdom
4EUCTR2013-001744-65-GB
(EUCTR)
22/10/201431/03/2014A 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 ColitisA 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 LLCNULLNot 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): noUnited States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden
5EUCTR2013-001744-65-PL
(EUCTR)
20/10/201419/08/2014A 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 ColitisA 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 LLCNULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Hungary;Slovakia;Canada;Belgium;Poland;Israel;Netherlands;Germany;United Kingdom;Sweden
6EUCTR2013-001744-65-HU
(EUCTR)
24/09/201415/07/2014A 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 ColitisA 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 LLCNULLNot RecruitingFemale: yes
Male: yes
132Phase 3United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom
7EUCTR2013-001744-65-SK
(EUCTR)
11/09/201417/07/2014A 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 ColitisA 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 LLCNULLNot 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): noUnited States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden
8EUCTR2011-000164-10-GB
(EUCTR)
04/01/201319/09/2012Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative ColitisA 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 LLCNULLNot RecruitingFemale: yes
Male: yes
64Phase 1United States;Slovakia;Poland;Australia;United Kingdom
9EUCTR2012-002023-15-AT
(EUCTR)
21/09/201204/09/2012Mesacol: The effect of mesalazine on molecular pathways ofcell adhesion in ulcerative colitisMesacol: The effect of mesalazine on molecular pathways ofcell adhesion in ulcerative colitis - Mesacol Ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Mezavant 1200 mg magensaftresistente Retardtabletten
INN or Proposed INN: MESALAZINE
Other descriptive name: 5-aminosalicylic acid
Medizinische Universität Wien, Universitätsklinik für Innere Medizin 3, Abteilung für Gastroenterologie und HepatologieNULLNot RecruitingFemale: yes
Male: yes
12Phase 2Austria
10EUCTR2009-017044-13-DE
(EUCTR)
03/11/201016/06/2010A 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 colitisA 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 IncNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany
11EUCTR2009-017044-13-BE
(EUCTR)
14/09/201006/05/2010A 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 colitisA 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 LLCNULLNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Belgium;Poland;South Africa;Germany
12EUCTR2009-017044-13-IE
(EUCTR)
10/08/201020/04/2010A 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 colitisA 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 LLCNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany
13EUCTR2009-017044-13-CZ
(EUCTR)
05/08/201028/05/2010A 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 colitisA 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 LLCNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Hungary;Canada;Poland;South Africa;Germany;United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Czech Republic
14EUCTR2009-017044-13-FR
(EUCTR)
27/07/201022/06/2010A 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 ColitisA 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 IncNULLNot RecruitingFemale: yes
Male: yes
1000Phase 4France;Czech Republic;Hungary;Belgium;Spain;Ireland;Germany;United Kingdom
15EUCTR2009-017044-13-HU
(EUCTR)
21/07/201026/04/2010A 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 colitisA 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 LLCNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany
16EUCTR2009-017044-13-GB
(EUCTR)
30/06/201017/03/2010A 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 LLCNULLNot 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): yesUnited States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Belgium;South Africa;Germany
17EUCTR2009-017044-13-ES
(EUCTR)
25/06/201019/04/2010Estudio 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 ColitisEstudio 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.NULLNot RecruitingFemale: yes
Male: yes
1000Phase 4France;Czech Republic;Hungary;Belgium;Spain;Ireland;Germany;United Kingdom
18EUCTR2004-004184-29-DK
(EUCTR)
10/09/200910/10/2007A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
830Phase 3Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
19EUCTR2008-007292-25-IT
(EUCTR)
24/03/200916/03/2009AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08 Patients with established diagnosis of left-sided UC (rectum-sigmoid colon or colon up to the splenic flexure)
MedDRA version: 9.1;Level: LLT;Classification code 10024123;Term: Left-sided ulcerative (chronic) colitis
Trade Name: MEZAVANT
INN or Proposed INN: Mesalazine
Trade Name: ASACOL
INN or Proposed INN: Mesalazine
GIULIANINULLNot RecruitingFemale: yes
Male: yes
Phase 3Italy
20EUCTR2004-004184-29-NL
(EUCTR)
15/01/200817/10/2007A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
826Phase 3Portugal;Czech Republic;Hungary;Spain;Denmark;Germany;Netherlands;United Kingdom;Sweden
21EUCTR2004-004184-29-PT
(EUCTR)
14/12/200711/10/2007A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
826Phase 3Hungary;Portugal;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
22EUCTR2004-004184-29-SE
(EUCTR)
22/11/200727/09/2007A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
830Phase 3Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
23EUCTR2004-004184-29-GB
(EUCTR)
31/05/200523/02/2005A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot Recruiting Female: yes
Male: yes
826 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Czech Republic;Hungary;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden
24EUCTR2004-004184-29-CZ
(EUCTR)
13/04/200511/04/2005A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets.
Product Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
826Phase 3Portugal;Hungary;Germany;United Kingdom;Czech Republic;Netherlands;Denmark;Spain;Sweden
25EUCTR2004-004184-29-HU
(EUCTR)
30/03/200510/02/2005A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets.
Product Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
826Phase 3Portugal;Czech Republic;Hungary;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden