Salofalk® 1000mg Granu-Stix® ( DrugBank: - )
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 | 8 |
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 | EUCTR2004-001216-31-SI (EUCTR) | 22/12/2005 | 26/10/2005 | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816 | Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Estonia;Czech Republic;Hungary;Slovenia;Lithuania;Latvia;Germany | |||
| 2 | EUCTR2004-001216-31-CZ (EUCTR) | 17/08/2005 | 17/08/2005 | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816 | Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Germany;Czech Republic;Estonia;Latvia;Lithuania | |||
| 3 | EUCTR2004-001216-31-SK (EUCTR) | 28/07/2005 | 23/05/2005 | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816 | Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 3 | Estonia;Czech Republic;Hungary;Slovenia;Slovakia;Lithuania;Latvia;Germany | ||
| 4 | EUCTR2004-001216-31-HU (EUCTR) | 28/07/2005 | 20/06/2005 | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816 | Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania | |||
| 5 | EUCTR2004-001216-31-LV (EUCTR) | 25/07/2005 | 25/07/2005 | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816 | Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania | |||
| 6 | EUCTR2004-001216-31-LT (EUCTR) | 06/06/2005 | 28/04/2005 | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816 | Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania | |||
| 7 | EUCTR2004-001216-31-DE (EUCTR) | 30/05/2005 | 04/04/2005 | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816 | Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania | |||
| 8 | EUCTR2004-001216-31-EE (EUCTR) | 11/01/2005 | 20/09/2005 | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Therapy of active ulcerative colitis MedDRA version: 7.1;Level: LLT;Classification code 10058816 | Trade Name: Salofalk® 1000mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania |