Asacol Delayed Release Tablets
( 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 | 19 |
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 19 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 |
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1 | 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 Ma ... | 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 t ... | 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 |
2 | 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 | ||
3 | 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 Activ ... | 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 |
4 | 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 | |||
5 | EUCTR2007-004732-23-LV (EUCTR) | 27/02/200820080227 | 28/02/200820080228 | A Multicenter, Randomized, Partially 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, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequ ... | A Multicenter, Randomized, Partially 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, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequ ... | Mild to moderately active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative Mild to moderately active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 1000 ... | Product Name: Mesalamine Delayed Release Tablets 400mg INN or Proposed INN: MESALAZINE Trade Name: Asacol Product Name: Asacol Delayed-Release Tablets INN or Proposed INN: MESALAZINE Product Name: Mesalamine Delayed Release Tablets400mg INN or Proposed INN: MESALAZINE Trade Name: Asac ... | EMET Pharmaceuticals LLC | NULL | Not Recruiting | Female: yes Male: yes | 435 | Estonia;Latvia;Poland | |||
6 | 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 | ||
7 | 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 ... | 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 Tablets400 mg to the Reference ... | Mild to Moderate Ulcerative Colitis | Drug: Placebo;Drug: Mesalamine | EMET Pharmaceuticals, LLC | Eagle Pharmaceuticals, Inc. | Completed | 18 Years | N/A | Both | Phase 3 | NULL | |
8 | EUCTR2004-004184-29-PT (EUCTR) | 14/12/200720071214 | 11/10/200720071011 | 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 | Hungary;Portugal;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden | ||
9 | EUCTR2004-004184-29-SE (EUCTR) | 22/11/200720071122 | 27/09/200720070927 | 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 | ||
10 | EUCTR2007-004732-23-EE (EUCTR) | 22/10/200720071022 | 23/10/200720071023 | A Multicenter, Randomized, Partially 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, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequ ... | A Multicenter, Randomized, Partially 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, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequ ... | Mild to moderately active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative Mild to moderately active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 1000 ... | Product Name: Mesalamine Delayed Release Tablets 400mg INN or Proposed INN: MESALAZINE Trade Name: Asacol Product Name: Asacol Delayed-Release Tablets INN or Proposed INN: MESALAZINE Product Name: Mesalamine Delayed Release Tablets400mg INN or Proposed INN: MESALAZINE Trade Name: Asac ... | EMET Pharmaceuticals LLC | NULL | Not Recruiting | Female: yes Male: yes | 435 | Estonia;Latvia;Poland |