2622U90 Duramycin ( DrugBank: Duramycin )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
299嚢胞性線維症3

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2006-006693-24-CZ
(EUCTR)
16/07/200809/05/2007A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
INN or Proposed INN: Not available
Other descriptive name: 2622U90 Duramycin
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
2EUCTR2006-006693-24-DE
(EUCTR)
29/08/200729/05/2007A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
INN or Proposed INN: Not available
Other descriptive name: 2622U90 Duramycin
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
160Phase 2;Phase 3France;Hungary;Czech Republic;Poland;Spain;Austria;Germany;Italy;Sweden
3EUCTR2006-006693-24-PL
(EUCTR)
11/10/2007A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
INN or Proposed INN: Not available
Other descriptive name: 2622U90 Duramycin
AOP Orphan Pharmaceuticals AGNULLNAFemale: yes
Male: yes
160Phase 2France;Hungary;Czech Republic;Spain;Poland;Austria;Germany;Italy;Sweden