Tobrineb/Bramitob ( DrugBank: - )


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5

299. 嚢胞性線維症


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2006-006215-68-FR
(EUCTR)
21/09/200906/08/2009A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSAA MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA cystic fibrosis and P. aeruginosa chronic infection
MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal
MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Bramitob
Product Name: Tobrineb/Bramitob
INN or Proposed INN: tobramycin
Trade Name: Tobi 300mg/5ml Nebuliser solution.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320Phase 3France;Hungary;Czech Republic;Spain;Germany
2EUCTR2006-006215-68-ES
(EUCTR)
22/08/200827/06/2008ENSAYO CLÍNICO MULTICÉNTRICO, MULTINACIONAL, ABIERTO, ALEATORIZADO, CON GRUPOS PARALELOS DE TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMICINA SOLUCIÓN PARA NEBULIZACIÓN, 300 mg DOS VECES AL DÍA EN VIALES UNIDOSIS DE 4 ML) EN COMPARACIÓN CON TOBI® EN EL TRATAMIENTO DE PACIENTES CON FIBROSIS QUÍSTICA E INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSAENSAYO CLÍNICO MULTICÉNTRICO, MULTINACIONAL, ABIERTO, ALEATORIZADO, CON GRUPOS PARALELOS DE TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMICINA SOLUCIÓN PARA NEBULIZACIÓN, 300 mg DOS VECES AL DÍA EN VIALES UNIDOSIS DE 4 ML) EN COMPARACIÓN CON TOBI® EN EL TRATAMIENTO DE PACIENTES CON FIBROSIS QUÍSTICA E INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA Infección pulmonar crónica por P. aeruginosa en pacientes con fibrosis quística
MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal
MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Bramitob
Product Name: Tobrineb/Bramitob
INN or Proposed INN: tobramicina
Trade Name: Tobi 300mg/5ml Solución para inhalación por nebulizador.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320Phase 3France;Hungary;Czech Republic;Spain;Germany
3EUCTR2006-006215-68-DE
(EUCTR)
14/08/200818/12/2008A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSAA MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA cystic fibrosis and P. aeruginosa chronic infection
MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal
MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Bramitob
Product Name: Tobrineb/Bramitob
INN or Proposed INN: tobramycin
Trade Name: Tobi 300mg/5ml Nebuliser solution.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320France;Hungary;Czech Republic;Spain;Germany
4EUCTR2006-006215-68-HU
(EUCTR)
13/08/200825/06/2008A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSAA MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA cystic fibrosis and P. aeruginosa chronic infection
MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal
MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Bramitob
Product Name: Tobrineb/Bramitob
INN or Proposed INN: tobramycin
Trade Name: Tobi 300mg/5ml Nebuliser solution.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320Hungary;Germany;Czech Republic;France;Spain
5EUCTR2006-006215-68-CZ
(EUCTR)
29/07/200816/06/2008A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSAA MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA cystic fibrosis and P. aeruginosa chronic infection
MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal
MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Bramitob
Product Name: Tobrineb/Bramitob
INN or Proposed INN: tobramycin
Trade Name: Tobi 300mg/5ml Nebuliser solution.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320Phase 3France;Hungary;Czech Republic;Spain;Germany