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11

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2000034924
2020-10-302020-07-24Phase I clinical tolerance and pharmacokinetics of TGP capsule in ChinesePhase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese Rheumatoid arthritis, Sjogren's syndromeGroup 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 MedicineNULLPendingBothGroup 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 tolerPhase 1China

53. シェーグレン症候群


臨床試験数 : 305 薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2000034924
2020-10-302020-07-24Phase I clinical tolerance and pharmacokinetics of TGP capsule in ChinesePhase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese Rheumatoid arthritis, Sjogren's syndromeGroup 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 MedicineNULLPendingBothGroup 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 tolerPhase 1China

84. サルコイドーシス


臨床試験数 : 149 薬物数 : 202 - (DrugBank : 78) / 標的遺伝子数 : 66 - 標的パスウェイ数 : 169
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02024555
(ClinicalTrials.gov)
March 201426/12/2013Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary SarcoidosisInvestigation of the Efficacy of Antimycobacterial Therapy on Pulmonary Sarcoidosis Phase II Randomized, Double-blind, Placebo-controlled TrialSarcoidosis; Antimycobacterial TherapyDrug: Levofloxacin;Drug: Ethambutol;Drug: Azithromycin;Drug: Rifampin;Drug: PlaceboVanderbilt UniversityNational Heart, Lung, and Blood Institute (NHLBI)Completed18 YearsN/AAll97Phase 2United States

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
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-000955-16-AT
(EUCTR)
28/01/202007/01/2020Characterization of lung concentrations of the antibiotics piperacillin/tazobactam and levofloxacinPulmonary 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 ViennaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
18Phase 4Austria
2EUCTR2010-019634-26-GB
(EUCTR)
18/08/201107/02/2011Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) PatientsA 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 Nebuliser Solution
INN or Proposed INN: TOBRAMYCIN
Mpex Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
330 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Ireland;Israel;Germany;United Kingdom
3EUCTR2010-019634-26-DE
(EUCTR)
24/05/201125/01/2011Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) PatientsA 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.NULLNot RecruitingFemale: yes
Male: yes
330Phase 3France;United States;Canada;Ireland;Israel;Germany;United Kingdom
4EUCTR2010-019634-26-IE
(EUCTR)
03/05/201115/02/2011Trial of Aeroquin versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis PatientsA 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.NULLNot RecruitingFemale: yes
Male: yes
330Phase 3France;United States;Canada;Ireland;Israel;Germany;United Kingdom
5NCT01270347
(ClinicalTrials.gov)
January 20113/1/2011Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) PatientsPhase 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 PatientsCystic FibrosisDrug: MP-376 (Levofloxacin Solution for Inhalation);Drug: TIS (Tobramycin Inhalation Solution)Horizon Pharma USA, Inc.Forest LaboratoriesCompleted12 YearsN/AAll267Phase 3United States;France;Germany;Ireland;Israel;United Kingdom
6NCT01180634
(ClinicalTrials.gov)
November 201010/8/2010MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic FibrosisA 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 PatientsCystic FibrosisDrug: MP-376 (Levofloxacin solution for Inhalation);Drug: PlaceboHorizon Pharma USA, Inc.Forest LaboratoriesCompleted12 YearsN/AAll330Phase 3United States;Australia;Canada;Israel;New Zealand
7NCT00840333
(ClinicalTrials.gov)
April 20095/2/2009Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Pediatric (CF) PatientsA 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 FibrosisDrug: MP-376 (Levofloxacin solution for Inhalation)Horizon Pharma USA, Inc.NULLCompleted6 Years16 YearsAll27Phase 1United States
8EUCTR2008-001728-30-DE
(EUCTR)
26/08/200807/05/2008A 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 PatientsA 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.NULLNot RecruitingFemale: yes
Male: yes
190Phase 2Netherlands;Germany
9EUCTR2008-001728-30-NL
(EUCTR)
18/08/200830/05/2008A 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.NULLNot RecruitingFemale: yes
Male: yes
190Phase 2Germany;Netherlands
10NCT00503490
(ClinicalTrials.gov)
June 200716/7/2007Safety, Pharmacokinetic and Pharmacodynamic Study of MP-376 in Patients With Cystic FibrosisPhase 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 PatientsCystic FibrosisDrug: MP-376 (Levofloxacin solution for Inhalation);Drug: placeboHorizon Pharma USA, Inc.NULLCompleted16 YearsN/AAll40Phase 1United States
11EUCTR2010-019634-26-FR
(EUCTR)
08/02/2011A 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 PatientsA 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.NULLNAFemale: yes
Male: yes
330Phase 3France;Ireland;Germany;United Kingdom