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 | EUCTR2013-001205-84-BE (EUCTR) | 11/03/2016 | 17/02/2015 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC | Maintenance of remission in ulcerative colitis (UC) MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands | ||
| 2 | EUCTR2013-001205-84-HU (EUCTR) | 07/03/2016 | 04/01/2016 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC | Maintenance of remission in ulcerative colitis (UC) MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Hungary;Belgium;Poland;Germany;Latvia;Netherlands | ||
| 3 | EUCTR2013-001205-84-AT (EUCTR) | 13/10/2015 | 02/09/2015 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC | Maintenance of remission in ulcerative colitis (UC) MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands | ||
| 4 | EUCTR2013-001205-84-SK (EUCTR) | 23/03/2015 | 05/02/2015 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC | Maintenance of remission in ulcerative colitis (UC) 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: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands | ||
| 5 | EUCTR2013-001205-84-LV (EUCTR) | 26/02/2015 | 23/12/2014 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC | Maintenance of remission in ulcerative colitis (UC) MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Latvia;Germany;Netherlands | ||
| 6 | EUCTR2013-001205-84-PL (EUCTR) | 20/01/2015 | 22/09/2014 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC | Maintenance of remission in ulcerative colitis (UC) MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Poland;Belgium;Germany;Latvia;Netherlands | ||
| 7 | EUCTR2013-001205-84-DE (EUCTR) | 13/01/2015 | 08/08/2014 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC | Maintenance of remission in ulcerative colitis (UC) 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: gastro-resistant phosphatidylcholine granules Product Code: LT-02 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands |