Budesonide (9 mg) (DrugBank: Budesonide)
9 diseases告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
66 | IgA腎症 | 0 |
93 | 原発性胆汁性胆管炎[原発性胆汁性肝硬変 (~2017.3)] | 0 |
94 | 原発性硬化性胆管炎 | 0 |
95 | 自己免疫性肝炎 | 0 |
96 | クローン病 | 4 |
97 | 潰瘍性大腸炎 | 1 |
98 | 好酸球性消化管疾患 | 0 |
228 | 閉塞性細気管支炎 | 0 |
299 | 嚢胞性線維症 | 0 |
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 |
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1 | EUCTR2004-001213-34-GB (EUCTR) | 30/01/2007 | 19/08/2008 | Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD | Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD | moderately active Crohn’s disease (200 < CDAI < 400) MedDRA version: 7.0;Level: PT;Classification code 10011401 | Trade Name: Salofalk INN or Proposed INN: mesalazine Other descriptive name: 5-Aminosalicyl acid Trade Name: Budenofalk INN or Proposed INN: budesonide | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 370 | Czech Republic;United Kingdom | |||
2 | EUCTR2004-001213-34-SK (EUCTR) | 16/12/2004 | 16/08/2005 | Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD | Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD | moderately active Crohn’s disease (200 < CDAI < 400) MedDRA version: 7.0;Level: PT;Classification code 10011401 | INN or Proposed INN: mesalazine INN or Proposed INN: budesonide | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 370 | Phase 3 | Czech Republic;Slovakia;United Kingdom | ||
3 | EUCTR2004-001213-34-CZ (EUCTR) | 02/11/2004 | 02/11/2004 | Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD | Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD | moderately active Crohn’s disease (200 < CDAI < 400) MedDRA version: 7.0;Level: PT;Classification code 10011401 | INN or Proposed INN: mesalazine INN or Proposed INN: budesonide | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 370 | United Kingdom;Czech Republic | |||
4 | NCT00300118 (ClinicalTrials.gov) | September 2004 | 7/3/2006 | Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD) | Double-blind, Double-dummy, Randomized, Multicentre Study to Compare the Efficacy and Safety of Oral Budesonide (9 mg) and Oral Mesalazine (4.5 g) in Moderately Active Crohn's Disease Patients | Crohn's Disease | Drug: budesonide;Drug: mesalazine | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 70 Years | Both | 311 | Phase 3 | Germany |
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 | NCT03412682 (ClinicalTrials.gov) | March 2, 2018 | 22/1/2018 | To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis | A Phase 3, Multi-centre, Randomised, Double-blind, Active-controlled, Parallel-group Trial Investigating the Efficacy and Safety of FE 999315 Following 8 Weeks of Treatment for Mild to Moderate Active Ulcerative Colitis in Japanese Subjects | Colitis, Ulcerative | Drug: Budesonide (6 mg);Drug: Budesonide (9 mg);Drug: Mesalazine (3,600 mg) | Ferring Pharmaceuticals | NULL | Completed | 16 Years | 75 Years | All | 274 | Phase 3 | Japan |