TOP1288 Rectal solution ( DrugBank: TOP-1288 )
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 | 7 |
97. 潰瘍性大腸炎
臨床試験数 : 2,527 / 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| 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 | EUCTR2016-000390-20-BG (EUCTR) | 29/08/2016 | 18/07/2016 | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study toEvaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg RectalSolution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patientswith Moderate to Severe Disease Activity | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution | TOPIVERT Pharma Limited | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom | ||
| 2 | EUCTR2016-000390-20-CZ (EUCTR) | 18/07/2016 | 18/07/2016 | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate Disease Activity | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | Symptomatic Ulcerative Colitis Patients with Moderate to Severe DiseaseActivity MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution | TOPIVERT Pharma Limited | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom | ||
| 3 | EUCTR2016-000390-20-LT (EUCTR) | 15/07/2016 | 05/07/2016 | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution | TOPIVERT Pharma Limited | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom | ||
| 4 | EUCTR2016-000390-20-HU (EUCTR) | 05/07/2016 | 14/06/2016 | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution | TOPIVERT Pharma Limited | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Czech Republic;Hungary;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom | ||
| 5 | EUCTR2016-000390-20-PL (EUCTR) | 28/06/2016 | 16/06/2016 | English A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study toEvaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg RectalSolution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patientswith Moderate to Severe Disease Activity | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution | TOPIVERT Pharma Limited | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom | ||
| 6 | EUCTR2016-000390-20-LV (EUCTR) | 17/06/2016 | 14/06/2016 | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study toEvaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg RectalSolution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patientswith Moderate to Severe Disease Activity | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution | TOPIVERT Pharma Limited | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom | ||
| 7 | EUCTR2016-000390-20-GB (EUCTR) | 10/06/2016 | 06/06/2016 | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | Symptomatic Ulcerative Colitis Patients with Moderate Disease Activity MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TOP1288 Rectal solution INN or Proposed INN: Not Applied for Other descriptive name: TOP1288 rectal solution | TOPIVERT Pharma Limited | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom |