Denufosol ( DrugBank: Denufosol )


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9

299. 嚢胞性線維症


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01181622
(ClinicalTrials.gov)
August 201012/8/2010A Safety and Tolerability Study of Denufosol in 2-4 Year OldsA Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 7-Day Safety and Tolerability Study of Denufosol Tetrasodium Inhalation Solution Administered Via PARI LC® Star in Patients 2 to 4 Years of Age With Cystic FibrosisCystic FibrosisDrug: denufosol tetrasodium Inhalation Solution;Drug: 0.9% w/v sodium chloride solutionMerck Sharp & Dohme Corp.NULLCompleted2 Years4 YearsBoth25Phase 2United States
2NCT00846781
(ClinicalTrials.gov)
February 200918/2/2009Study 08-114 Open-label Extension of Study 08-110 - A Multi-Center Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease (P08642)Cystic FibrosisDrug: Denufosol tetrasodium Inhalation SolutionMerck Sharp & Dohme Corp.NULLTerminated5 YearsN/ABoth308Phase 3United States;Australia;Canada;New Zealand
3NCT00625612
(ClinicalTrials.gov)
February 200812/2/2008Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung DiseaseA Phase 3, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease and FEV1 Greater Than or Equal to 75% Predicted But Less Than or Equal to 110% PredictedCystic FibrosisDrug: Denufosol Tetrasodium (INS37217) Inhalation Solution;Drug: PlaceboMerck Sharp & Dohme Corp.NULLCompleted5 YearsN/ABoth466Phase 3United States;Australia;Canada;New Zealand
4NCT00425165
(ClinicalTrials.gov)
July 200719/1/2007Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung DiseaseA Randomized, Double-Blind, Two Way Crossover Evaluation of the Effects of a Single Dose of Denufosol Tetrasodium (INS37217) Inhalation Solution Versus Placebo (0.9% Sodium Chloride Solution) on Mucociliary Clearance in Patients With Mild to Moderate Cystic Fibrosis Lung DiseaseCystic FibrosisDrug: denufosol tetrasodium (INS37217) Inhalation SolutionMerck Sharp & Dohme Corp.NULLTerminated10 YearsN/ABoth6Phase 2United States
5NCT00357279
(ClinicalTrials.gov)
July 200625/7/2006Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung DiseaseA Multi-Center, Double-Blind, Placebo-Controlled Randomized, Efficacy and Safety Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Mild Cystic Fibrosis Lung DiseaseCystic FibrosisDrug: denufosol tetrasodium (INS37217) Inhalation Solution;Drug: Placebo - 0.9% w/v sodium chloride solutionMerck Sharp & Dohme Corp.NULLCompleted5 YearsN/ABoth352Phase 3United States;Canada
6NCT00130182
(ClinicalTrials.gov)
August 200511/8/2005A Study in Pediatric Patients With Cystic Fibrosis Lung DiseaseA Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Pediatric Patients With Cystic Fibrosis Lung DiseaseCystic FibrosisDrug: denufosol tetrasodium (INS37217)Merck Sharp & Dohme Corp.NULLCompleted5 Years7 YearsBoth13Phase 2United States
7NCT00103714
(ClinicalTrials.gov)
January 200514/2/2005Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung DiseaseA Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Cystic Fibrosis Lung DiseaseCystic FibrosisDrug: denufosol tetrasodium (INS37217)Merck Sharp & Dohme Corp.NULLCompleted8 Years50 YearsBoth72Phase 2United States
8NCT00056147
(ClinicalTrials.gov)
April 20036/3/2003Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung DiseaseMulti-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of INS37217 Inhalation Solution in Subjects With Mild to Moderate Cystic Fibrosis Lung DiseaseCystic FibrosisDrug: denufosol tetrasodium (INS37217)Merck Sharp & Dohme Corp.Cystic Fibrosis Foundation TherapeuticsCompleted8 Years50 YearsBoth90Phase 2United States
9NCT00034515
(ClinicalTrials.gov)
June 200129/4/2002A Study in Adult and Pediatric Patients With Cystic FibrosisPh 1b/2a Study to Assess Levels of INS37217 and Placebo Treatment With Maximum Tolerated Dose Administered by Inhalation Via the Pari LC Star Nebulizer in Adult and Pediatric CF PatientsCystic FibrosisDrug: denufosol tetrasodium (INS37217) Inhalation SolutionMerck Sharp & Dohme Corp.NULLCompleted5 YearsN/ABoth63Phase 1/Phase 2United States