Mesalazine 500 mg gastro-resistant tablets (salofalk® 500 mg) (DrugBank: Mesalazine)
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 | 5 |
| 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 | EUCTR2012-001830-32-LT (EUCTR) | 04/02/2013 | 04/10/2012 | A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC | Active ulcerative colitis 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 Name: Mesalazine 1000 mg gastro-resistant tablets Product Code: Mesalazine 1000 mg gastro-resistant tablets INN or Proposed INN: Mesalazine Trade Name: Salofalk® 500 mg gastro-resistant tablet Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg) Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa INN or Proposed INN: Mesalazine | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia | ||
| 2 | EUCTR2012-001830-32-PL (EUCTR) | 01/02/2013 | 18/10/2012 | A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC | Active ulcerative colitis 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 Name: Mesalazine 1000 mg gastro-resistant tablets Product Code: Mesalazine 1000 mg gastro-resistant tablets INN or Proposed INN: Mesalazine Trade Name: Salofalk® 500 mg gastro-resistant tablet Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg) Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa INN or Proposed INN: Mesalazine | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia | ||
| 3 | EUCTR2012-001830-32-DE (EUCTR) | 15/01/2013 | 14/08/2012 | A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC | Active ulcerative colitis 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 Name: Mesalazine 1000 mg gastro-resistant tablets Product Code: Mesalazine 1000 mg gastro-resistant tablets INN or Proposed INN: Mesalazine Trade Name: Salofalk® 500 mg gastro-resistant tablet Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg) Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa INN or Proposed INN: Mesalazine | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany | ||
| 4 | EUCTR2012-001830-32-HU (EUCTR) | 04/10/2012 | 16/08/2012 | A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC | Active ulcerative colitis 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 Name: Mesalazine 1000 mg gastro-resistant tablets Product Code: Mesalazine 1000 mg gastro-resistant tablets INN or Proposed INN: Mesalazine Trade Name: Salofalk® 500 mg gastro-resistant tablet Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg) Product Code: Salofalk® 500 mg tablets INN or Proposed INN: Mesalazine | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia | ||
| 5 | EUCTR2012-001830-32-LV (EUCTR) | 02/10/2012 | 05/09/2012 | A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC | Active ulcerative colitis MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mesalazine 1000 mg gastro-resistant tablets Product Code: Mesalazine 1000 mg gastro-resistant tablets INN or Proposed INN: Mesalazine Trade Name: Salofalk® 500 mg gastro-resistant tablet Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg) Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa INN or Proposed INN: Mesalazine | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Russian Federation;Germany;Latvia |