K(d)pt (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 | 7 |
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 |
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1 | EUCTR2011-002462-20-SK (EUCTR) | 19/11/2012 | 27/09/2011 | Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis | Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study | Acute mild to moderate ulcerative colitis. MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate | Dr August Wolff GmbH & Co KG Arzneimittel | NULL | Not Recruiting | Female: yes Male: yes | Hungary;Czech Republic;Slovakia;Poland;Germany;Italy | ||||
2 | EUCTR2011-002462-20-IT (EUCTR) | 02/01/2012 | 08/03/2012 | Prospective clinical study, where patients are receiving or the study drug or an inactive drug called placebo wihtout knowing which of the two drugs is taken, even the Investigator is aware of the therapy taken by the patients. Patients are assigned to a specific treatment according to a randomization list. The study is performed to assess the effects and tolerability of K(D)PT in ulcerative colitis. | Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis:PoC study | mild to moderate ulcerative colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Lysine-D-proline-threonine Product Code: K(D)PT INN or Proposed INN: NA Other descriptive name: L-Lysyl-D-Prolyl-LThreonine acetate, lyophilisate | DR. AUGUST WOLFF GMBH & CO. KG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Czech Republic;Slovakia;Poland;Germany;Italy | |||
3 | EUCTR2011-002462-20-PL (EUCTR) | 27/12/2011 | 20/10/2011 | Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis | Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study | Acute mild to moderate ulcerative colitis. MedDRA version: 15.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate | Dr August Wolff GmbH & Co KG Arzneimittel | NULL | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Czech Republic;Poland;Germany;Italy | |||
4 | EUCTR2011-002462-20-HU (EUCTR) | 07/12/2011 | 22/09/2011 | Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis | Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study | Acute mild to moderate ulcerative colitis. MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate | Dr August Wolff GmbH & Co KG Arzneimittel | NULL | Not Recruiting | Female: yes Male: yes | Czech Republic;Hungary;Poland;Germany;Italy | ||||
5 | EUCTR2011-002462-20-CZ (EUCTR) | 24/11/2011 | 20/09/2011 | Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis | Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study | Acute mild to moderate ulcerative colitis. MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate | Dr August Wolff GmbH & Co KG Arzneimittel | NULL | Not Recruiting | Female: yes Male: yes | Hungary;Czech Republic;Poland;Germany;Italy | ||||
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 |
6 | EUCTR2011-002462-20-DE (EUCTR) | 25/10/2011 | 13/09/2011 | Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis | Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study | Acute mild to moderate ulcerative colitis. MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KdPT Product Code: 20 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 50 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Product Name: KdPT Product Code: 100 mg Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate | Dr August Wolff GmbH & Co KG Arzneimittel | NULL | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Czech Republic;Poland;Germany;Italy | |||
7 | EUCTR2010-023494-19-SE (EUCTR) | 10/02/2011 | 27/12/2010 | A Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative Colitis | A Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative Colitis | Ulcerative colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Lysine-D-Proline-Threonine Product Code: K(D)PT | Dr. August Wolff GmbH & Co. KG Arzneimittel | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Sweden |