TIP (Tobramycin inhalation powder) ( DrugBank: Tobramycin )


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15

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
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2011-002000-32-HU
(EUCTR)
25/11/201105/09/2011A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler 28 mg inhalációs por, kemény kapszula
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
150Phase 4France;United States;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy
2EUCTR2011-002000-32-ES
(EUCTR)
17/11/201128/09/2011A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis - not available Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI PODHALER
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Farmaceutica S. ANULLNot RecruitingFemale: yes
Male: yes
150Phase 4United States;France;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy
3EUCTR2009-016734-26-BG
(EUCTR)
01/07/201015/06/2010A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Estonia;Lithuania;Bulgaria;Latvia
4EUCTR2009-016734-26-LT
(EUCTR)
23/03/201020/01/2010A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Estonia;Lithuania;Bulgaria;Latvia
5EUCTR2009-016734-26-LV
(EUCTR)
17/02/201011/01/2010A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
6EUCTR2009-016734-26-EE
(EUCTR)
08/01/201015/12/2009A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Estonia;Lithuania;Bulgaria;Latvia
7EUCTR2008-002318-22-LT
(EUCTR)
07/09/200922/01/2009A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Other descriptive name: TBM100C
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
8EUCTR2008-004764-39-LT
(EUCTR)
07/09/200922/01/2009A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 13.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
9EUCTR2008-002318-22-BG
(EUCTR)
20/08/200928/08/2009A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Estonia;Bulgaria;Latvia;Lithuania
10EUCTR2008-004764-39-BG
(EUCTR)
20/08/200928/08/2009A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 12.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Estonia;Bulgaria;Latvia;Lithuania
11EUCTR2008-004764-39-EE
(EUCTR)
30/07/200923/07/2009A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
12EUCTR2008-004764-39-LV
(EUCTR)
19/06/200908/05/2009A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
13EUCTR2008-002318-22-LV
(EUCTR)
13/05/200928/01/2009A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
14EUCTR2008-002318-22-EE
(EUCTR)
06/05/200927/02/2009A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
15EUCTR2011-002000-32-FR
(EUCTR)
22/09/2011A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
150Phase 4United States;France;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy