97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details


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

  
4 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
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-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
4EUCTR2013-001744-65-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