97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
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
| 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 | EUCTR2013-003060-31-BG (EUCTR) | 18/06/2014 | 10/04/2014 | A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis | A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy. (NATRUL-4) | Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia | ||
| 2 | EUCTR2013-003060-31-PL (EUCTR) | 11/06/2014 | 19/03/2014 | A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis | A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy. (NATRUL-4) | Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia | ||
| 3 | EUCTR2013-003060-31-CZ (EUCTR) | 10/04/2014 | 04/02/2014 | A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis | A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy.(NATRUL-4) | Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia | ||
| 4 | EUCTR2013-003060-31-HU (EUCTR) | 02/04/2014 | 31/01/2014 | A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis | A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy. (NATRUL-4) | Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Czech Republic;Hungary;Poland;Ukraine;Lithuania;Bulgaria;Latvia | ||
| 5 | EUCTR2013-003060-31-LV (EUCTR) | 17/02/2014 | 16/12/2013 | A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis | A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy. (NATRUL-4) | Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia | ||
| 6 | EUCTR2013-003060-31-LT (EUCTR) | 11/02/2014 | 30/12/2013 | A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis | A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy. (NATRUL-4) | Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia | ||
| 7 | EUCTR2013-002116-27-BG (EUCTR) | 19/12/2013 | 16/10/2013 | A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis | A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis (NATRUL-3) | Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia | ||
| 8 | EUCTR2013-002116-27-LT (EUCTR) | 14/11/2013 | 06/08/2013 | A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis | A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis (NATRUL-3) | Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;Korea, Republic of | ||
| 9 | EUCTR2013-002116-27-LV (EUCTR) | 28/10/2013 | 26/06/2013 | A Placebo Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis | A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis (NATRUL-3) | Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;Korea, Republic of | ||
| 10 | EUCTR2013-002116-27-HU (EUCTR) | 24/10/2013 | 24/07/2013 | A Placebo Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis | A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis (NATRUL-3) | Ulcerative Colitis (UC) MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Czech Republic;Hungary;Poland;Ukraine;Lithuania;Bulgaria;Latvia;Korea, Republic of | ||
| 11 | EUCTR2013-002116-27-CZ (EUCTR) | 09/10/2013 | 08/08/2013 | A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis | A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis (NATRUL-3) | Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Other descriptive name: AND (Andrographolide) Other descriptive name: NAND (Neoandrographolide) Other descriptive name: DAND (14-Deoxyandrographolide) Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) Other descriptive name: CLA (Chlorogenic acid) Other descriptive name: AODG (Apigenin-7-O-glucuronide) | Nutrition Science Partners Limited | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;Korea, Republic of | ||
| 12 | NCT01882764 (ClinicalTrials.gov) | June 2013 | 17/6/2013 | HMPL-004 Maintenance Treatment in Subjects With Mild to Moderate Ulcerative Colitis | A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects With Mild to Moderate Ulcerative Colitis With Clinical Remission or Response From Induction Therapy. (NATRUL-4) | Ulcerative Colitis | Drug: HMPL-004;Drug: Placebo | Hutchison Medipharma Limited | Nutrition Science Partners Limited | Terminated | 18 Years | N/A | All | 66 | Phase 3 | United States |
| 13 | NCT01805791 (ClinicalTrials.gov) | March 2013 | 4/3/2013 | A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis | A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis | Ulcerative Colitis | Drug: HMPL-004 1800 mg/day;Drug: Placebo;Drug: HMPL-004 2400 mg/day | Hutchison Medipharma Limited | NULL | Terminated | 18 Years | 75 Years | All | 201 | Phase 3 | United States |
| 14 | EUCTR2007-005166-12-DE (EUCTR) | 29/07/2008 | 15/01/2008 | A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine | A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine | active mild to moderate ulcerative colitis defined as a Mayo clinical score of 4-10 points MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis | Product Name: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA (ethanol extract) Product Name: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA (ethanol extract) | Hutchison MediPharma Enterprises Limited | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Germany | ||
| 15 | NCT00659802 (ClinicalTrials.gov) | February 7, 2008 | 8/4/2008 | Phase II Study of HMPL-004 in Patients With Ulcerative Colitis | A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis With or Without Mesalamine | Ulcerative Colitis | Drug: HMPL-004 low dose;Drug: Placebo;Drug: HMPL-004 high dose | Hutchison Medipharma Limited | NULL | Completed | 18 Years | N/A | All | 224 | Phase 2 | United States |