299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
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. | 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 | EUCTR2011-000441-20-ES (EUCTR) | 21/09/2011 | 11/11/2011 | ESTUDIO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA | ESTUDIO ALEATORIZADO, ABIERTO, CONTROLADO CON MEDICAMENTO ACTIVO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA - TR02-108 | Infección pulmonar con Pseudomonas aeruginosa/ colonización en pacientes con fibrosis quística MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Amikacina liposomal (Arikace?) INN or Proposed INN: Sulfato de amikacina Trade Name: TOBI 300mg/ 5ml solución para inhalación con nebulizador INN or Proposed INN: tobramicina | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;Netherlands | ||
| 2 | EUCTR2005-004389-17-HU (EUCTR) | 28/12/2005 | 24/10/2005 | SAFETY AND TOLERABILITY STUDY OF SLIT AMIKACIN 500 MG ONCE DAILY FOR 14 DAYS BY INHALATION IN CYSTIC FIBROSIS STUDY SUBJECTS CHRONICALLY INFECTED WITH PSEUDOMONAS AERUGINOSA | SAFETY AND TOLERABILITY STUDY OF SLIT AMIKACIN 500 MG ONCE DAILY FOR 14 DAYS BY INHALATION IN CYSTIC FIBROSIS STUDY SUBJECTS CHRONICALLY INFECTED WITH PSEUDOMONAS AERUGINOSA | Cystic Fibrosis with mild to moderate obstructive lung disease and chronic infection with Pseudomonas aeruginosa | Product Name: SLIT Amikacin Product Code: TR02 INN or Proposed INN: amikacin Other descriptive name: amikin, amiklin, amicacin, BB-K8, Biklin, Fabianol, Kaminax, Mikavir, Novamin, Pierami | Transave, Inc | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | Hungary | ||
| 3 | EUCTR2005-004899-21-BE (EUCTR) | 22/12/2005 | 12/01/2006 | Safety and tolerability study of SLIT(TM) Amikacin 500 mg once daily for 14 days by inhalation in cystic fibrosis study subjects chronically infected with Pseudomonas aeruginosa. - NA | Safety and tolerability study of SLIT(TM) Amikacin 500 mg once daily for 14 days by inhalation in cystic fibrosis study subjects chronically infected with Pseudomonas aeruginosa. - NA | Cystic Fibrosis | Product Name: SLIT(TM) Amikacin Product Code: TR02 INN or Proposed INN: Amikacin Other descriptive name: amikin®, amiklin, amicacin, BB-K8, Biklin®, Fabianol®, Kaminax, Mikavir, Novamin®, Pierami | Transave, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 15 | Belgium |