Asacol®
( DrugBank: - / KEGG DRUG: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 97 | 潰瘍性大腸炎 | 24 |
97. 潰瘍性大腸炎
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
Showing 1 to 10 of 24 trials
| 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 | EUCTR2019-002070-31-DK (EUCTR) | 05/09/201920190905 | 24/06/201920190624 | Compliance to treatment with new single-pill 5-ASA for patients with Ulcerative Colitis (EASI-trial) Compliance to treatment with new single-pill 5-ASA for patients with Ulcerative Colitis (EASI-trial) ... | Adherence of a 1.600 mg single tablet 5-ASA treatment of Ulcerative colitis (EASI-trial) | Ulcerative colitis (UC) belongs to the group of inflammatory bowel diseases. The disease course is unpredictable and characterised by chronic inflammation of the colonic mucosa, where acute attacks are followed by periods of remission. Development of UC is characterized by a dysregulated immune response and barrier dysfunction caused by genetic susceptibility and environmental triggers. UC only involves the colon, starting in the rectum and extending to proximal segments of the colon.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] Ulcerative colitis (UC) belongs to the group of inflammatory bowel diseases. The disease course is u ... | Trade Name: Asacol® INN or Proposed INN: MESALAZINE | Copenhagen University Hospital Hvidovre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 4 | Denmark | ||
| 2 | NCT01257386 (ClinicalTrials.gov) | November 201020101100 | 8/12/201020101208 | Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis | Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis | Active Ulcerative Colitis | Drug: Asacol®;Drug: Mesalazine | Tillotts Pharma AG | Zeria Pharmaceutical | Completed | 18 Years | 64 Years | Both | 251 | Phase 3 | China |
| 3 | NCT01257399 (ClinicalTrials.gov) | November 201020101100 | 8/12/201020101208 | Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase | Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase | Ulcerative Colitis in Remission | Drug: Asacol®;Drug: Mesalazine | Tillotts Pharma AG | Zeria Pharmaceutical | Completed | 18 Years | 64 Years | Both | 251 | Phase 3 | China |
| 4 | NCT01004185 (ClinicalTrials.gov) | October 200920091000 | 27/10/200920091027 | Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis Assessing the Safety/Efficacy of Asacol®Given Every 12 Hours to Children and Adolescents for the Mai ... | A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8g/Day) 400 mg Delayed-release Tablets Given Twice Daily for 26 Weeks to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol®(1.2 to ... | Ulcerative Colitis | Drug: Asacol 400 mg | Warner Chilcott | NULL | Terminated | 5 Years | 17 Years | All | 39 | Phase 3 | United States;Canada;Croatia;Poland;Romania;Russian Federation |
| 5 | EUCTR2004-004184-29-DK (EUCTR) | 10/09/200920090910 | 10/10/200720071010 | 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 A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to comp ... | 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 A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to comp ... | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative coli ... | 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 Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Name: Mezavant XL ... | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 830 | Phase 3 | Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden | ||
| 6 | NCT00713310 (ClinicalTrials.gov) | December 200820081200 | 9/7/200820080709 | Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis Assessing the Safety/Efficacy of Asacol®Given Every 12 Hours to Children and Adolescents With Active ... | Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/Day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents With Mildly-to-Moderately Active Ulcerative Colitis Study to Assess the Safety and Efficacy of Asacol®(1.2 to 4.8 g/Day) Administered as 400 mg Delayed- ... | Ulcerative Colitis | Drug: Asacol 400 mg | Warner Chilcott | NULL | Completed | 5 Years | 17 Years | All | 83 | Phase 3 | United States;Canada;Croatia;Poland;Romania |
| 7 | NCT00679432 (ClinicalTrials.gov) | June 200820080600 | 14/5/200820080514 | (CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis (CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and ... | 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. Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet For ... | Ulcerative Colitis | Procedure: Blood sampling, endoscopy;Drug: budesonide-MMX® 6 mg;Drug: budesonide-MMX® 9 mg;Drug: Placebo;Drug: Asacol® 400 mg Procedure: Blood sampling, endoscopy;Drug: budesonide-MMX® 6 mg;Drug: budesonide-MMX® 9 mg;Drug: Pla ... | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | 75 Years | All | 510 | Phase 3 | United States;Canada;India;Mexico |
| 8 | EUCTR2007-004732-23-PL (EUCTR) | 05/05/200820080505 | 12/05/200820080512 | A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, PARALLEL DESIGN, THREE-ARM, BIOEQUIVALENCE STUDY WITH CLINICAL ENDPOINTS COMPARING MESALAMINE DELAYED RELEASE TABLETS 400mg TO THE REFERENCE LISTED DRUG ASACOL® DELAYED RELEASE TABLETS 400mg IN PATIENTS WITH MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS.) A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, PARALLEL DESIGN, THREE-ARM, BIOEQUIVALENCE S ... | A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, PARALLEL DESIGN, THREE-ARM, BIOEQUIVALENCE STUDY WITH CLINICAL ENDPOINTS COMPARING MESALAMINE DELAYED RELEASE TABLETS 400mg TO THE REFERENCE LISTED DRUG ASACOL® DELAYED RELEASE TABLETS 400mg IN PATIENTS WITH MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS.) A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, PARALLEL DESIGN, THREE-ARM, BIOEQUIVALENCE S ... | Mild to moderately active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative Mild to moderately active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 1004 ... | Product Name: Mesalamine INN or Proposed INN: MESALAZINE Trade Name: Asacol Product Name: Asacol Delayed-Release Tablets INN or Proposed INN: MESALAZINE Product Name: Mesalamine INN or Proposed INN: MESALAZINE Trade Name: Asacol Product Name: Asacol Delaye ... | EMET Pharmaceuticals, LLC | NULL | Not Recruiting | Female: yes Male: yes | 435 | Estonia;Latvia;Poland | |||
| 9 | EUCTR2004-004184-29-NL (EUCTR) | 15/01/200820080115 | 17/10/200720071017 | 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 A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to comp ... | 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 A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to comp ... | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative coli ... | 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 Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets Product Name: Mezavant XL ... | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Czech Republic;Hungary;Spain;Denmark;Germany;Netherlands;United Kingdom;Sweden | ||
| 10 | NCT01045018 (ClinicalTrials.gov) | January 200820080100 | 17/12/200920091217 | A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis A BE Study Comparing Mesalamine 400 mg to ASACOL®400 mg in Patients With Mild To Moderately Active U ... | BE Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400 mg to the Reference Listed Drug ASACOL® Delayed Release Tablets 400 mg in Patients With Mild to Moderately Active Ulcerative Colitis BE Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400 mg to the Referenc ... | Mild to Moderate Ulcerative Colitis | Drug: Placebo;Drug: Mesalamine | EMET Pharmaceuticals, LLC | Eagle Pharmaceuticals, Inc. | Completed | 18 Years | N/A | Both | Phase 3 | NULL |