Amikacin (DrugBank: Amikacin)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 60 | 再生不良性貧血 | 1 |
| 299 | 嚢胞性線維症 | 51 |
| 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 | EUCTR2011-005152-34-ES (EUCTR) | 26/03/2012 | 22/11/2011 | Clinical trial to reduce duration of antibiotic therapy in in-hospital patients with haematological diseases that develop fever and low white blood cell count (neutropenia). | Randomized open label clinical trial directed to optimize the duration of empirical antimicrobial therapy in haematologic patients with febrile neutropenia | In-hospital adult patients diagnosed with acute leukemia, lymphoproliferative syndrome, multiple myeloma, myelodysplastic syndrome, aplastic anemia or who have received autologous or allogeneic transplantation of hematopoietic progenitors, with febrile neutropenia without etiological diagnosis. MedDRA version: 14.0;Level: PT;Classification code 10016288;Term: Febrile neutropenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.0;Level: LLT;Classification code 10066156;Term: Empiric treatment;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | INN or Proposed INN: ACICLOVIR Other descriptive name: ACICLOVIR INN or Proposed INN: AMIKACIN Other descriptive name: AMIKACIN INN or Proposed INN: AMPHOTERICINE B, LIPOSOME Other descriptive name: AMPHOTERICINE B, LIPOSOME INN or Proposed INN: CASPOFUNGIN ACETATE Other descriptive name: CASPOFUNGIN ACETATE INN or Proposed INN: CEFEPIME DIHYDROCHLORIDE MONOHYDRATE Other descriptive name: CEFEPIME DIHYDROCHLORIDE MONOHYDRATE INN or Proposed INN: CIPROFLOXACIN Other descriptive name: CIPROFLOXACIN INN or Proposed INN: TRIMETHOPRIM SULFATE Other descriptive name: TRIMETHOPRIM SULFATE INN or Proposed INN: SULFAMETH | José Miguel Cisneros Herreros | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Spain |
| 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 | NCT02535130 (ClinicalTrials.gov) | August 2015 | 24/8/2015 | Evaluation of Nebulization and Positive Expiratory Pressure Combination | Cystic Fibrosis;Healthy Subjects | Device: Positive expiratory pressure;Drug: amikacine nebulization | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | NULL | Recruiting | 16 Years | 55 Years | Both | 15 | N/A | Belgium | |
| 2 | NCT02489955 (ClinicalTrials.gov) | February 2015 | 18/5/2015 | Antibiotic Nephrotoxicity in Adult Patients With Cystic Fibrosis | Prospective Randomised Trial of 'Area Under the Curve' (AUC) Dosing Strategy for Intravenous Tobramycin Versus Standard Trough Dosing for Pulmonary Exacerbations in Adult Patients With Cystic Fibrosis (CF) | Cystic Fibrosis | Drug: Amikacin;Drug: Tobramycin;Drug: Colomycin | The Leeds Teaching Hospitals NHS Trust | NULL | Recruiting | 18 Years | N/A | Both | N/A | United Kingdom | |
| 3 | ChiCTR-IPC-15005915 | 2015-01-31 | 2014-07-06 | A Randomized, Controlled Study of Combined the therapy of bronchoalveolar lavage and Amikacin injection in Patients with Acute Exacerbation of Bronchiectasis | A Randomized, Controlled Study of Combined the therapy of bronchoalveolar lavage and Amikacin injection in Patients with Acute Exacerbation of Bronchiectasis | non-cystic fibrosis bronchiectasis | Experimental group:Routine treatment combining with the therapy of bronchoalveolar lavage and local drug injection (Amikacin); | Department of Respiratory Medicine, Shanghai Pulmonary Hospital, Tongji University School of Medicine | NULL | Recruiting | 18 | 80 | Both | Experimental group:50; | NULL | |
| 4 | NCT02081963 (ClinicalTrials.gov) | March 2014 | 6/3/2014 | Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis | A Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis | Non-Cystic Fibrosis Bronchiectasis | Drug: Amikacin;Drug: Normal saline | Qilu Hospital of Shandong University | NULL | Completed | 18 Years | 80 Years | All | 178 | Phase 4 | China |
| 5 | NCT02084043 (ClinicalTrials.gov) | March 2014 | 8/3/2014 | In Vitro Assessment of a Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation | In Vitro Comparison of Continuous and Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation: Analysis of Inhaled and Lost Doses. | Respiratory Diseases;Lung Diseases;Cystic Fibrosis;COPD;Asthma | Drug: Nebulization of Amikacin during NIV (RR: 15 cycles/minute);Drug: Nebulization of Amikacin during NIV (RR: 25 cycles/minute) | University Hospital St Luc, Brussels | Université Catholique de Louvain;University of Applied Sciences of Western Switzerland;School of Gestion and Engineering Vaud, Switzerland | Completed | N/A | N/A | Both | 3 | N/A | Belgium;Switzerland |
| 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 | EUCTR2011-000443-24-NL (EUCTR) | 25/04/2013 | 06/07/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
| 7 | EUCTR2011-000443-24-DK (EUCTR) | 14/12/2012 | 22/07/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | |||
| 8 | NCT01316276 (ClinicalTrials.gov) | October 5, 2012 | 14/3/2011 | Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (ARIKACE™) in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: Liposomal amikacin for inhalation | Insmed Incorporated | NULL | Completed | 6 Years | N/A | All | 206 | Phase 3 | Austria;Belgium;Bulgaria;Canada;Denmark;France;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Poland;Serbia;Slovakia;Spain;United Kingdom |
| 9 | EUCTR2011-000441-20-NL (EUCTR) | 11/09/2012 | 06/07/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 13.1;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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany;United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom | |||
| 10 | NCT02201082 (ClinicalTrials.gov) | September 2012 | 20/2/2014 | Evaluation of the Timing of the Nebulization Related to the Physiotherapy Session | Cystic Fibrosis | Procedure: Airway clearance technique;Drug: Amikacin nebulization | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | NULL | Completed | 16 Years | 50 Years | Both | 15 | N/A | Belgium | |
| 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 |
| 11 | EUCTR2011-000441-20-BG (EUCTR) | 13/06/2012 | 03/05/2012 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 17.1;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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Serbia;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany | |||
| 12 | EUCTR2011-000443-24-SE (EUCTR) | 24/05/2012 | 07/06/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden | |||
| 13 | EUCTR2011-000441-20-IE (EUCTR) | 02/05/2012 | 26/05/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Code: TOBI INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
| 14 | EUCTR2011-000443-24-IT (EUCTR) | 10/04/2012 | 19/03/2012 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;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: Liposomal Amikacin Product Code: NA INN or Proposed INN: AMIKACIN SULFATE | INSMED INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 250 | Greece;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Canada;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | |||
| 15 | EUCTR2011-000441-20-DK (EUCTR) | 29/03/2012 | 22/07/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany | |||
| 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 |
| 16 | NCT01315678 (ClinicalTrials.gov) | February 29, 2012 | 14/3/2011 | Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections | Randomized, Open-Label, Active-Controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa | Pseudomonas Aeruginosa Infection | Drug: Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer.;Drug: Tobramycin inhalation solution using a PARI LC® Plus nebulizer. | Insmed Incorporated | NULL | Completed | 6 Years | N/A | All | 302 | Phase 3 | Austria;Belgium;Bulgaria;Canada;Denmark;France;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Poland;Serbia;Slovakia;Spain;Sweden;United Kingdom |
| 17 | NCT01315691 (ClinicalTrials.gov) | February 29, 2012 | 14/3/2011 | Study to Evaluate Arikace™ in CF Patients With Chronic Infection Due to Pseudomonas Aeruginosa | Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikace™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: Liposomal amikacin for inhalation;Drug: Placebo for liposomal amikacin for inhalation | Insmed Incorporated | NULL | Withdrawn | 6 Years | N/A | All | 0 | Phase 3 | NULL |
| 18 | EUCTR2011-000441-20-BE (EUCTR) | 30/01/2012 | 25/05/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis 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: Liposomal Amikacin (Arikace™) Product Code: N/A INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Name: TOBI Product Code: N/A INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany | ||
| 19 | EUCTR2011-000443-24-BE (EUCTR) | 30/01/2012 | 25/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;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: Liposomal Amikacin (Arikace™) Product Code: N/A INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
| 20 | EUCTR2011-000443-24-PL (EUCTR) | 20/01/2012 | 06/10/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 16.1;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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
| 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 |
| 21 | EUCTR2011-000443-24-DE (EUCTR) | 11/10/2011 | 30/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 17.1;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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
| 22 | EUCTR2011-000442-38-BG (EUCTR) | 03/10/2011 | 05/07/2011 | Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa | Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;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: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden | |||
| 23 | EUCTR2011-000443-24-BG (EUCTR) | 03/10/2011 | 28/07/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
| 24 | EUCTR2011-000441-20-IT (EUCTR) | 01/10/2011 | 08/03/2012 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection/colonisation in patients with cystic fibrosis MedDRA version: 14.1;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: Liposomal Amikacin (Arikace™) Product Code: NA INN or Proposed INN: AMIKACIN SULFATE Trade Name: Tobi INN or Proposed INN: TOBRAMYCIN | INSMED INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Greece;Canada;Spain;Ireland;Denmark;Austria;Bulgaria;Netherlands;United Kingdom;Italy | |||
| 25 | EUCTR2011-000443-24-ES (EUCTR) | 22/09/2011 | 03/11/2011 | Estudio de seguridad y tolerabilidad a largo plazo de la administración abierta Arikace en pacientes con fibrosis quística con infección crónica por Pseudomonas aeruginosa | Estudio de seguridad y tolerabilidad a largo plazo de la administración abierta de amicacina liposomal para inhalación (Arikace) en pacientes con fibrosis quística con infección crónica por Pseudomonas aeruginosa - NCT0131627 | Infeccion pulmonar por Pseudomonas Aeruginosa/ colonizacion en pacientes con fibrosis quistica 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: Liposomal Amikacin (Arikace TM) INN or Proposed INN: Sulfato de amikacina | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
| 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 |
| 26 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Australia;United Kingdom;Slovakia;Canada;Belgium;Denmark;Spain;United States;Greece;Poland | |||
| 27 | EUCTR2011-000442-38-ES (EUCTR) | 21/09/2011 | 11/11/2011 | Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa | Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaESTUDIO ALEATORIZADO, CONTROLADO CON PLACEBO, DOBLE CIEGO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE™ EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis 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: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Poland;Spain;Ukraine;Australia;Bulgaria;New Zealand;Sweden | |||
| 28 | EUCTR2011-000441-20-DE (EUCTR) | 19/09/2011 | 30/05/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Name: TOBI INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany | |||
| 29 | EUCTR2011-000443-24-GR (EUCTR) | 09/08/2011 | 23/06/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis 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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
| 30 | EUCTR2011-000443-24-IE (EUCTR) | 05/08/2011 | 26/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
| 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 |
| 31 | EUCTR2011-000443-24-GB (EUCTR) | 03/08/2011 | 24/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
| 32 | EUCTR2011-000441-20-GB (EUCTR) | 03/08/2011 | 24/05/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis 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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
| 33 | EUCTR2011-000443-24-FR (EUCTR) | 28/07/2011 | 31/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 13.1;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: Liposomal Amikacin (Arikace™) Product Code: NA INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
| 34 | EUCTR2011-000443-24-AT (EUCTR) | 22/07/2011 | 27/06/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden | |||
| 35 | EUCTR2011-000441-20-AT (EUCTR) | 19/07/2011 | 21/06/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
| 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 |
| 36 | EUCTR2011-000441-20-GR (EUCTR) | 15/07/2011 | 22/06/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis 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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
| 37 | EUCTR2011-000443-24-SK (EUCTR) | 04/07/2011 | 20/02/2014 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 16.1;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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Germany;New Zealand;Sweden;United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands | ||
| 38 | EUCTR2011-000441-20-SK (EUCTR) | 04/07/2011 | 25/11/2014 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 17.1;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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany | |||
| 39 | EUCTR2011-000443-24-HU (EUCTR) | 29/06/2011 | 11/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis 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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
| 40 | EUCTR2011-000441-20-HU (EUCTR) | 29/06/2011 | 20/04/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis 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: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
| 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 |
| 41 | NCT03905642 (ClinicalTrials.gov) | January 8, 2009 | 2/4/2019 | Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase | Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) in Cystic Fibrosis Patients With Chronic Infections Due to Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: Arikayce™ | Insmed Incorporated | NULL | Completed | 6 Years | N/A | All | 49 | Phase 2 | Belgium;Hungary;North Macedonia;Poland;Serbia;Slovakia;Ukraine;Macedonia, The Former Yugoslav Republic of |
| 42 | NCT00558844 (ClinicalTrials.gov) | January 2008 | 13/11/2007 | Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa | Phase 1b/2a Multidose Safety and Tolerability Study of Liposomal Amikacin for Inhalation (Arikayce™) in Cystic Fibrosis Patient With Chronic Infections Due to Pseudomonas Aeruginosa. | Cystic Fibrosis | Drug: Arikayce™ 560 mg;Drug: Placebo for 560 mg;Drug: Arikayce™ 70 mg;Drug: Arikayce™ 140 mg;Drug: Placebo for 70 mg / 140 mg | Insmed Incorporated | NULL | Completed | 6 Years | N/A | All | 41 | Phase 1;Phase 2 | United States |
| 43 | EUCTR2006-006980-22-BE (EUCTR) | 27/06/2007 | 19/07/2007 | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin sulfate | Transave, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Belgium | |||
| 44 | EUCTR2006-006980-22-HU (EUCTR) | 14/06/2007 | 03/04/2007 | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Liposomal Amikacin (Arikace™) | Transave, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Belgium | |||
| 45 | EUCTR2006-006980-22-SK (EUCTR) | 17/05/2007 | 23/04/2007 | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Transave, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Slovakia;Poland;Belgium | |||
| 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 |
| 46 | NCT00777296 (ClinicalTrials.gov) | February 22, 2007 | 15/10/2008 | Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™) | Phase 2a Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™) In Cystic Fibrosis Patients With Chronic Infections Due To Pseudomonas Aeruginosa. | Cystic Fibrosis | Drug: ARIKACE™;Drug: Placebo | Insmed Incorporated | NULL | Completed | 6 Years | N/A | All | 66 | Phase 1;Phase 2 | Belgium;Hungary;North Macedonia;Poland;Serbia;Slovakia;Ukraine;Bulgaria;Macedonia, The Former Yugoslav Republic of |
| 47 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Hungary | |||
| 48 | 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 | |||
| 49 | NCT00153634 (ClinicalTrials.gov) | March 2004 | 8/9/2005 | Standard vs. Biofilm Susceptibility Testing in Cystic Fibrosis (CF) | Standard vs. Biofilm Susceptibility Testing in CF | Cystic Fibrosis;Chronic Bronchitis | Drug: IV amikacin;Drug: PO azithromycin;Drug: IV ceftazidime;Drug: PO ciprofloxacin;Drug: IV meropenem;Drug: IV piperacillin-tazobactam;Drug: IV ticarcillin-clavulanate;Drug: IV tobramycin | Seattle Children's Hospital | Cystic Fibrosis Foundation Therapeutics | Completed | 14 Years | N/A | Both | 75 | N/A | United States |
| 50 | EUCTR2011-000442-38-PL (EUCTR) | 01/08/2011 | Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa | Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis 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: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden | |||
| 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 |
| 51 | EUCTR2006-006980-22-PL (EUCTR) | 22/08/2007 | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Transave, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Slovakia;Belgium;Poland |