Levofloxacin (DrugBank: Levofloxacin)
4 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 1 |
| 53 | シェーグレン症候群 | 1 |
| 84 | サルコイドーシス | 1 |
| 299 | 嚢胞性線維症 | 10 |
| 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 | ChiCTR2000034924 | 2020-10-30 | 2020-07-24 | Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese | Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese | Rheumatoid arthritis, Sjogren's syndrome | Group 1 (single dose tolerance test):test drug or placebo;Group2(single dose tolerance test):test drug or placebo;Group3(single dose tolerance test):test drug or placebo;Group4(single dose tolerance test):test drug or placebo;Group 5(single dose tolerance test):test drug or placebo;Group 6(single dose tolerance test):test drug or placebo;Group 7 (multiple dose tolerance test) :test drug or placebo;Group 8 (multiple dose tolerance test):test drug or placebo;Group 9 (single dose pharmacokinetic test):test drug;Group 10 (single dose pharmacokinetic test):test drug;Group 11 (single dose pharmacokinetic test):test drug;Group 12 (single dose pharmacokinetic test):test drug;Group 13 (multiple dose pharmacokinetic test):test drug;Group 14 (food impact test):test drug;Group 15 (antibiotic effect test):test drug and levofloxacin tablets; | The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | NULL | Pending | Both | Group 1 (single dose tolerance test):4;Group2(single dose tolerance test):6;Group3(single dose tolerance test):8;Group4(single dose tolerance test):8;Group 5(single dose tolerance test):8;Group 6(single dose tolerance test):8;Group 7 (multiple dose toler | Phase 1 | China |
| 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 | ChiCTR2000034924 | 2020-10-30 | 2020-07-24 | Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese | Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese | Rheumatoid arthritis, Sjogren's syndrome | Group 1 (single dose tolerance test):test drug or placebo;Group2(single dose tolerance test):test drug or placebo;Group3(single dose tolerance test):test drug or placebo;Group4(single dose tolerance test):test drug or placebo;Group 5(single dose tolerance test):test drug or placebo;Group 6(single dose tolerance test):test drug or placebo;Group 7 (multiple dose tolerance test) :test drug or placebo;Group 8 (multiple dose tolerance test):test drug or placebo;Group 9 (single dose pharmacokinetic test):test drug;Group 10 (single dose pharmacokinetic test):test drug;Group 11 (single dose pharmacokinetic test):test drug;Group 12 (single dose pharmacokinetic test):test drug;Group 13 (multiple dose pharmacokinetic test):test drug;Group 14 (food impact test):test drug;Group 15 (antibiotic effect test):test drug and levofloxacin tablets; | The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | NULL | Pending | Both | Group 1 (single dose tolerance test):4;Group2(single dose tolerance test):6;Group3(single dose tolerance test):8;Group4(single dose tolerance test):8;Group 5(single dose tolerance test):8;Group 6(single dose tolerance test):8;Group 7 (multiple dose toler | Phase 1 | China |
| 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 | NCT02024555 (ClinicalTrials.gov) | March 2014 | 26/12/2013 | Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary Sarcoidosis | Investigation of the Efficacy of Antimycobacterial Therapy on Pulmonary Sarcoidosis Phase II Randomized, Double-blind, Placebo-controlled Trial | Sarcoidosis; Antimycobacterial Therapy | Drug: Levofloxacin;Drug: Ethambutol;Drug: Azithromycin;Drug: Rifampin;Drug: Placebo | Vanderbilt University | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 18 Years | N/A | All | 97 | Phase 2 | United States |
| 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 | EUCTR2019-000955-16-AT (EUCTR) | 28/01/2020 | 07/01/2020 | Characterization of lung concentrations of the antibiotics piperacillin/tazobactam and levofloxacin | Pulmonary pharmacokinetics of piperacillin/tazobactam and levofloxacin in patients with chronic obstructive pulmonary disease or cystic fibrosis: Comparison of epithelial lining fluid, in-vivo microdialysis and tissue biopsy | Pneumonia;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Piperacillin/Tazobactam Kabi - Fresenius Kabi Austria INN or Proposed INN: piperacillin Other descriptive name: PIPERACILLIN INN or Proposed INN: tazobactam Other descriptive name: TAZOBACTAM Trade Name: Levofloxacin Kabi INN or Proposed INN: levofloxacin Other descriptive name: LEVOFLOXACIN HEMIHYDRATE | Medical University of Vienna | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 18 | Phase 4 | Austria | ||
| 2 | EUCTR2010-019634-26-DE (EUCTR) | 24/05/2011 | 25/01/2011 | Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients | A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution (TIS) in Stable Cystic Fibrosis Patients | Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders 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] | Product Name: Aeroquin Product Code: MP-376 INN or Proposed INN: levofloxacin Other descriptive name: levofloxacin hemihydrate Trade Name: TOBI 300 mg/5 ml Lösung für einen INN or Proposed INN: TOBRAMYCIN | Mpex Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | France;United States;Canada;Ireland;Israel;Germany;United Kingdom | ||
| 3 | EUCTR2010-019634-26-IE (EUCTR) | 03/05/2011 | 15/02/2011 | Trial of Aeroquin versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis Patients | A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy ofMP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis Patients | Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;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] | Product Name: Aeroquin Product Code: MP-376 INN or Proposed INN: levofloxacin Other descriptive name: levofloxacin hemihydrate Trade Name: TOBI INN or Proposed INN: TOBRAMYCIN | Mpex Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | France;United States;Canada;Ireland;Israel;Germany;United Kingdom | ||
| 4 | NCT01270347 (ClinicalTrials.gov) | January 2011 | 3/1/2011 | Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients | Phase 3, Open-label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin) vs. Tobramycin Inhalation Solution (TIS) in Stable CF Patients | Cystic Fibrosis | Drug: MP-376 (Levofloxacin Solution for Inhalation);Drug: TIS (Tobramycin Inhalation Solution) | Horizon Pharma USA, Inc. | Forest Laboratories | Completed | 12 Years | N/A | All | 267 | Phase 3 | United States;France;Germany;Ireland;Israel;United Kingdom |
| 5 | NCT01180634 (ClinicalTrials.gov) | November 2010 | 10/8/2010 | MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis | A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of MP-376 (Levofloxacin Inhalation Solution; Aeroquin™) In Stable Cystic Fibrosis Patients | Cystic Fibrosis | Drug: MP-376 (Levofloxacin solution for Inhalation);Drug: Placebo | Horizon Pharma USA, Inc. | Forest Laboratories | Completed | 12 Years | N/A | All | 330 | Phase 3 | United States;Australia;Canada;Israel;New Zealand |
| 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 | NCT00840333 (ClinicalTrials.gov) | April 2009 | 5/2/2009 | Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Pediatric (CF) Patients | A Phase 1B, Multi-Center, Open Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MP-376 Inhalation Solution Given Daily for 14 Days to Stable Pediatric Cystic Fibrosis Patients. | Cystic Fibrosis | Drug: MP-376 (Levofloxacin solution for Inhalation) | Horizon Pharma USA, Inc. | NULL | Completed | 6 Years | 16 Years | All | 27 | Phase 1 | United States |
| 7 | EUCTR2008-001728-30-DE (EUCTR) | 26/08/2008 | 07/05/2008 | A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study toEvaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable Cystic Fibrosis Patients | A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study toEvaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable Cystic Fibrosis Patients | Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung MedDRA version: 9.1;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: MP-376 Product Code: MP-376 INN or Proposed INN: levofloxacin | Mpex Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 2 | Netherlands;Germany | ||
| 8 | EUCTR2008-001728-30-NL (EUCTR) | 18/08/2008 | 30/05/2008 | A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study toEvaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable Cystic Fibrosis Patients - | Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung MedDRA version: 9.1;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: MP-376 Product Code: MP-376 INN or Proposed INN: levofloxacin | Mpex Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 2 | Germany;Netherlands | |||
| 9 | NCT00503490 (ClinicalTrials.gov) | June 2007 | 16/7/2007 | Safety, Pharmacokinetic and Pharmacodynamic Study of MP-376 in Patients With Cystic Fibrosis | Phase I, Single and Multi-dose, Placebo Controlled, Randomized, Dose-Escalation Study to Evaluate the Safety, Tolerability and PK Profile of MP-376 Using the PARI eFlow Nebulizer for 14 Days to CF Patients | Cystic Fibrosis | Drug: MP-376 (Levofloxacin solution for Inhalation);Drug: placebo | Horizon Pharma USA, Inc. | NULL | Completed | 16 Years | N/A | All | 40 | Phase 1 | United States |
| 10 | EUCTR2010-019634-26-FR (EUCTR) | 08/02/2011 | A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy ofMP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis Patients | A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy ofMP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis Patients | Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung MedDRA version: 9.1;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: Aeroquin Product Code: MP-376 INN or Proposed INN: levofloxacin Other descriptive name: levofloxacin hemihydrate Trade Name: TOBI 300 mg/5 ml, solution pour inhalation par nébuliseur INN or Proposed INN: TOBRAMYCIN | Mpex Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 330 | Phase 3 | France;Ireland;Germany;United Kingdom |