Oral budesonide (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)］ | 1 |
| 94 | 原発性硬化性胆管炎 | 0 |
| 95 | 自己免疫性肝炎 | 1 |
| 96 | クローン病 | 4 |
| 97 | 潰瘍性大腸炎 | 21 |
| 98 | 好酸球性消化管疾患 | 11 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00587119 (ClinicalTrials.gov) | December 2007 | 21/12/2007 | Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis | Open-Label Pilot Study Evaluating Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis. | Primary Biliary Cirrhosis;Autoimmune Hepatitis | Drug: Budesonide | Mayo Clinic | NULL | Withdrawn | 21 Years | 75 Years | Both | 0 | N/A | United States |
| 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 | NCT00587119 (ClinicalTrials.gov) | December 2007 | 21/12/2007 | Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis | Open-Label Pilot Study Evaluating Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis. | Primary Biliary Cirrhosis;Autoimmune Hepatitis | Drug: Budesonide | Mayo Clinic | NULL | Withdrawn | 21 Years | 75 Years | Both | 0 | N/A | United States |
| 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 | 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 | EUCTR2011-005115-82-LT (EUCTR) | 12/09/2012 | 24/05/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Hungary;Estonia;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 2 | EUCTR2011-005115-82-LV (EUCTR) | 15/06/2012 | 21/05/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Hungary;Estonia;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 3 | EUCTR2011-005115-82-EE (EUCTR) | 05/06/2012 | 09/05/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | United States;Hungary;Czech Republic;Estonia;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 4 | EUCTR2011-005115-82-BG (EUCTR) | 11/05/2012 | 11/04/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | 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 Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 5 | EUCTR2011-005115-82-CZ (EUCTR) | 18/04/2012 | 08/02/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 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 |
| 6 | EUCTR2011-005115-82-PL (EUCTR) | 10/04/2012 | 16/03/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 7 | EUCTR2011-005115-82-HU (EUCTR) | 26/03/2012 | 07/02/2012 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Estonia;Czech Republic;Hungary;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 8 | NCT01532648 (ClinicalTrials.gov) | January 27, 2012 | 13/12/2011 | Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients With Active, Mild or Moderate Ulcerative Colitis Not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis | Drug: Budesonide MMX®;Drug: Placebo;Drug: 5-ASA | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | 75 Years | All | 510 | Phase 3 | United States;Bulgaria;Canada;Czechia;Estonia;Hungary;Latvia;Lithuania;Poland;Russian Federation;Ukraine;Czech Republic |
| 9 | NCT01100112 (ClinicalTrials.gov) | February 2010 | 6/4/2010 | (CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release Tablets | Multicenter, Open-Label Efficacy and Safety Study of Oral Budesonide-MMX 9mg Extended Release Tablets in Patients With Mild to Moderate, Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Budesonide | Bausch Health Americas, Inc. | Cosmo Technologies Ltd | Completed | 18 Years | 75 Years | All | 61 | Phase 3 | India |
| 10 | EUCTR2006-004776-12-IT (EUCTR) | 15/10/2008 | 20/03/2009 | Efficacy and Safety of Oral Budesonide-MMX? (CB 01 02) 6 mg and 9 mg Extended Release Tablets in Patients with Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo with an Additional Reference Arm Evaluating EntocortEC. - CB-01-02/02 | Efficacy and Safety of Oral Budesonide-MMX? (CB 01 02) 6 mg and 9 mg Extended Release Tablets in Patients with Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo with an Additional Reference Arm Evaluating EntocortEC. - CB-01-02/02 | Patients with mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: Budesonide Trade Name: ENTOCORT CR INN or Proposed INN: Budesonide Product Name: Budesonide MMX Product Code: CB-01-02 INN or Proposed INN: Budesonide | COSMO TECHNOLOGIES LTD | NULL | Not Recruiting | Female: yes Male: yes | 492 | United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden | |||
| 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 |
| 11 | NCT00805285 (ClinicalTrials.gov) | October 2008 | 8/12/2008 | The Use of Oral Budesonide and Rectal Hydrocortisone for the Treatment of Active Ulcerative Colitis | Oral Budesonide and Rectal Hydrocortisone for the Treatment of Extensive Ulcerative Colitis: A Pilot Study | Inflammatory Bowel Disease;Ulcerative Colitis | Drug: Combination Oral Budesonide and Rectal Hydrocortisone | University of Maryland, Baltimore | NULL | Terminated | 18 Years | N/A | All | 1 | Phase 2 | United States |
| 12 | EUCTR2006-004776-12-SK (EUCTR) | 18/09/2008 | 16/07/2008 | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 | COSMO Technologies Ltd | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | France;Estonia;Slovakia;Belgium;Lithuania;Latvia;Italy;United Kingdom;Sweden | ||
| 13 | EUCTR2006-004776-12-EE (EUCTR) | 04/08/2008 | 11/06/2008 | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 | COSMO Technologies Ltd | NULL | Not Recruiting | Female: yes Male: yes | 492 | United Kingdom;Belgium;France;Estonia;Italy;Latvia;Lithuania;Sweden | |||
| 14 | EUCTR2006-004776-12-GB (EUCTR) | 23/07/2008 | 25/04/2008 | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 | COSMO Technologies Ltd | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | France;Estonia;Slovakia;Belgium;Lithuania;Latvia;Italy;United Kingdom;Sweden | ||
| 15 | EUCTR2006-004776-12-FR (EUCTR) | 07/07/2008 | 09/05/2008 | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 | COSMO Technologies Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 492 | United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden | |||
| 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 |
| 16 | EUCTR2006-004776-12-BE (EUCTR) | 01/07/2008 | 18/06/2008 | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 | COSMO Technologies Ltd | NULL | Not Recruiting | Female: yes Male: yes | 492 | United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden | |||
| 17 | EUCTR2006-004776-12-LT (EUCTR) | 17/06/2008 | 22/04/2008 | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 | COSMO Technologies Ltd | NULL | Not Recruiting | Female: yes Male: yes | 492 | United Kingdom;Belgium;Estonia;France;Italy;Latvia;Sweden;Lithuania | |||
| 18 | EUCTR2006-004776-12-SE (EUCTR) | 02/06/2008 | 10/04/2008 | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 | COSMO Technologies Ltd | NULL | Not Recruiting | Female: yes Male: yes | 492 | United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden | |||
| 19 | NCT00679380 (ClinicalTrials.gov) | June 2008 | 14/5/2008 | (CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis | Efficacy and Safety of Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablets in Patients With Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo With an Additional Reference Arm Evaluating Entocort®EC | Ulcerative Colitis | Procedure: Blood sampling, endoscopy;Drug: Budesonide MMX® 6 mg;Drug: Budesonide MMX® 9 mg;Drug: Entocort EC® 3 mg;Drug: Placebo | Bausch Health Americas, Inc. | Cosmo Technologies Ltd | Completed | 18 Years | 75 Years | All | 514 | Phase 3 | Australia;Belgium;Estonia;France;Israel;Italy;Latvia;Lithuania;Poland;Romania;Russian Federation;Slovakia;Sweden;Ukraine;United Kingdom |
| 20 | NCT00679432 (ClinicalTrials.gov) | June 2008 | 14/5/2008 | (CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis | Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg. | Ulcerative Colitis | Procedure: Blood sampling, endoscopy;Drug: budesonide-MMX® 6 mg;Drug: budesonide-MMX® 9 mg;Drug: Placebo;Drug: Asacol® 400 mg | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | 75 Years | All | 510 | Phase 3 | United States;Canada;India;Mexico |
| 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 |
| 21 | EUCTR2006-004776-12-LV (EUCTR) | 29/05/2008 | 29/04/2008 | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Mild or moderate active ulcerative colitis. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Budesonide-MMX™ Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 Trade Name: Entocort® CR INN or Proposed INN: budesonide Product Name: Budesonide-MMX Product Code: CB-01-02 INN or Proposed INN: budesonide Other descriptive name: CB-01-02 | COSMO Technologies Ltd | NULL | Not Recruiting | Female: yes Male: yes | 492 | United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden |
| 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 | EUCTR2017-003737-29-NL (EUCTR) | 01/04/2020 | 09/04/2019 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis | Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide oral suspension [0.2 mg/ml] INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2;Phase 3 | Portugal;Greece;Spain;Israel;Germany;Netherlands;United Kingdom | ||
| 2 | EUCTR2017-003737-29-GR (EUCTR) | 18/09/2019 | 03/09/2019 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis | Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2;Phase 3 | Portugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom | |||
| 3 | EUCTR2017-003737-29-GB (EUCTR) | 01/08/2019 | 24/10/2019 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis | Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2;Phase 3 | Portugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom | |||
| 4 | EUCTR2017-003737-29-PT (EUCTR) | 24/05/2019 | 29/01/2019 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis | Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide oral suspension [0.2 mg/ml] INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2;Phase 3 | Portugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom | ||
| 5 | EUCTR2017-003737-29-ES (EUCTR) | 11/04/2019 | 18/01/2019 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis | Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2;Phase 3 | Portugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom | |||
| 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 |
| 6 | NCT02736409 (ClinicalTrials.gov) | April 29, 2016 | 22/3/2016 | An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE) | A Phase 3, Multicenter, Double-blind Extension Study to Evaluate Maintenance of Efficacy of Oral Budesonide Suspension (OBS) and Long-term Treatment Effect of OBS in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis (EoE) | Eosinophilic Esophagitis (EoE) | Drug: Oral Budesonide Suspension (OBS);Drug: Placebo | Shire | NULL | Completed | 11 Years | 55 Years | All | 200 | Phase 3 | United States;United Kingdom |
| 7 | NCT02605837 (ClinicalTrials.gov) | December 7, 2015 | 4/11/2015 | A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved | Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis: A Phase 3 Randomized, Double-blind, Placebo-controlled Study | Eosinophilic Esophagitis (EoE) | Drug: Oral Budesonide Suspension (OBS);Drug: Placebo | Shire | NULL | Completed | 11 Years | 55 Years | All | 318 | Phase 3 | United States |
| 8 | NCT02125851 (ClinicalTrials.gov) | January 2014 | 21/2/2014 | Comparison of Esophageal Clearance Times of Oral Budesonide Preparations | Comparison of Esophageal Clearance Times of Oral Budesonide Preparations | Eosinophilic Esophagitis | Other: Xanthan Gum;Other: Honey | Walter Reed National Military Medical Center | NULL | Completed | 18 Years | 75 Years | Both | 24 | N/A | United States |
| 9 | NCT01821898 (ClinicalTrials.gov) | July 9, 2013 | 27/3/2013 | Eosinophilic Esophagitis Clinical Therapy Comparison Trial | Eosinophilic Esophagitis Clinical Therapy Comparison Trial | Eosinophilic Esophagitis | Drug: Oral Budesonide;Other: Elimination diet | Baylor College of Medicine | NULL | Terminated | 3 Years | 17 Years | All | 5 | Phase 2 | United States |
| 10 | NCT01642212 (ClinicalTrials.gov) | July 23, 2012 | 13/7/2012 | OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension | Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11-40 Years of Age)With Eosinophilic Esophagitis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study With an Open Label Extension | Eosinophilic Esophagitis (EoE) | Drug: Oral Budesonide Suspension (MB-9);Drug: Placebo | Shire | NULL | Completed | 11 Years | 40 Years | All | 93 | Phase 2 | United States |
| 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 |
| 11 | EUCTR2017-003737-29-DE (EUCTR) | 17/12/2018 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis | Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2;Phase 3 | Portugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom |