Asacol delayed-release tablets (DrugBank: -)
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 | 3 |
| 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 | EUCTR2007-004732-23-PL (EUCTR) | 05/05/2008 | 12/05/2008 | 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 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.) | 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 | Product Name: Mesalamine INN or Proposed INN: MESALAZINE Trade Name: Asacol Product Name: Asacol Delayed-Release Tablets INN or Proposed INN: MESALAZINE | EMET Pharmaceuticals, LLC | NULL | Not Recruiting | Female: yes Male: yes | 435 | Estonia;Latvia;Poland | |||
| 2 | EUCTR2007-004732-23-LV (EUCTR) | 27/02/2008 | 28/02/2008 | 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, 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 | Mild to moderately active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | 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 | EMET Pharmaceuticals LLC | NULL | Not Recruiting | Female: yes Male: yes | 435 | Estonia;Latvia;Poland | |||
| 3 | EUCTR2007-004732-23-EE (EUCTR) | 22/10/2007 | 23/10/2007 | 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, 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 | Mild to moderately active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | 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 | EMET Pharmaceuticals LLC | NULL | Not Recruiting | Female: yes Male: yes | 435 | Estonia;Latvia;Poland |