Dersalazine (DrugBank: Dersalazine)
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 | EUCTR2008-004610-27-SK (EUCTR) | 06/04/2009 | 09/02/2009 | A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis | A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis | Mild to moderate active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Dersalazine sodium Product Code: UR-12746-S INN or Proposed INN: dersalazine sodium Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: Mesalazine Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: mesalazine | Palau Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Slovakia;Spain;Belgium | ||
| 2 | EUCTR2008-004610-27-HU (EUCTR) | 26/02/2009 | 15/12/2008 | A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis | A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis | Mild to moderate active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Dersalazine sodium Product Code: UR-12746-S INN or Proposed INN: dersalazine sodium Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: Mesalazine Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: mesalazine | Palau Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Belgium;Spain | ||
| 3 | EUCTR2008-004610-27-BE (EUCTR) | 02/12/2008 | 24/07/2008 | A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis | A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis | Mild to moderate active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Dersalazine sodium Product Code: UR-12746-S INN or Proposed INN: dersalazine sodium Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: Mesalazine Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: mesalazine | Palau Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Belgium;Spain | ||
| 4 | NCT00808977 (ClinicalTrials.gov) | December 2008 | 15/12/2008 | A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis | A Double-blind, Randomised, Placebo and Mesalazine Controlled Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Active Colitis | Ulcerative Colitis | Drug: Dersalazine sodium;Drug: Mesalazine;Drug: Placebo | Palau Pharma S.A. | NULL | Completed | 18 Years | 65 Years | Both | 80 | Phase 2 | Belgium;Hungary;Slovakia;Spain |
| 5 | EUCTR2008-004610-27-ES (EUCTR) | 25/11/2008 | 26/09/2008 | Estudio fase II doble ciego, aleatorizado, controlado con placebo y mesalazina de seguridad y actividad de dersalazina en pacientes con colitis activa leve o moderada.A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis | Estudio fase II doble ciego, aleatorizado, controlado con placebo y mesalazina de seguridad y actividad de dersalazina en pacientes con colitis activa leve o moderada.A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis | Colitis ulcerosa de leve a moderadaMild to moderate ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Dersalazina sodica INN or Proposed INN: dersalazine sodium Trade Name: LIXACOL Product Name: LIXACOL INN or Proposed INN: MESALAZINA Other descriptive name: MESALAZINE Trade Name: LIXACOL Product Name: LIXACOL INN or Proposed INN: MESALAZINA Other descriptive name: MESALAZINE | Palau Pharma S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Hungary;Belgium;Spain |