299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details


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

  
11 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2010-019634-26-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
2EUCTR2010-019634-26-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
3EUCTR2010-019634-26-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
4NCT01270347
(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
5NCT01180634
(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
6NCT00840333
(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
7EUCTR2008-001728-30-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
8EUCTR2008-001728-30-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
9NCT00677365
(ClinicalTrials.gov)
June 200812/5/2008Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) PatientsPhase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable CF PatientsCystic Fibrosis (CF)Drug: MP-376;Drug: PlaceboHorizon Pharma USA, Inc.NULLCompleted16 YearsN/AAll151Phase 2United States;Germany;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