Denufosol (DrugBank: Denufosol)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 299 | Cystic fibrosis | 9 |
| 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 | NCT01181622 (ClinicalTrials.gov) | August 2010 | 12/8/2010 | A Safety and Tolerability Study of Denufosol in 2-4 Year Olds | A 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 Fibrosis | Cystic Fibrosis | Drug: denufosol tetrasodium Inhalation Solution;Drug: 0.9% w/v sodium chloride solution | Merck Sharp & Dohme Corp. | NULL | Completed | 2 Years | 4 Years | Both | 25 | Phase 2 | United States |
| 2 | NCT00846781 (ClinicalTrials.gov) | February 2009 | 18/2/2009 | Study 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 Fibrosis | Drug: Denufosol tetrasodium Inhalation Solution | Merck Sharp & Dohme Corp. | NULL | Terminated | 5 Years | N/A | Both | 308 | Phase 3 | United States;Australia;Canada;New Zealand | |
| 3 | NCT00625612 (ClinicalTrials.gov) | February 2008 | 12/2/2008 | Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease | A 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% Predicted | Cystic Fibrosis | Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution;Drug: Placebo | Merck Sharp & Dohme Corp. | NULL | Completed | 5 Years | N/A | Both | 466 | Phase 3 | United States;Australia;Canada;New Zealand |
| 4 | NCT00425165 (ClinicalTrials.gov) | July 2007 | 19/1/2007 | Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease | A 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 Disease | Cystic Fibrosis | Drug: denufosol tetrasodium (INS37217) Inhalation Solution | Merck Sharp & Dohme Corp. | NULL | Terminated | 10 Years | N/A | Both | 6 | Phase 2 | United States |
| 5 | NCT00357279 (ClinicalTrials.gov) | July 2006 | 25/7/2006 | Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease | A Multi-Center, Double-Blind, Placebo-Controlled Randomized, Efficacy and Safety Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease | Cystic Fibrosis | Drug: denufosol tetrasodium (INS37217) Inhalation Solution;Drug: Placebo - 0.9% w/v sodium chloride solution | Merck Sharp & Dohme Corp. | NULL | Completed | 5 Years | N/A | Both | 352 | Phase 3 | United States;Canada |
| 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 | NCT00130182 (ClinicalTrials.gov) | August 2005 | 11/8/2005 | A Study in Pediatric Patients With Cystic Fibrosis Lung Disease | A Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Pediatric Patients With Cystic Fibrosis Lung Disease | Cystic Fibrosis | Drug: denufosol tetrasodium (INS37217) | Merck Sharp & Dohme Corp. | NULL | Completed | 5 Years | 7 Years | Both | 13 | Phase 2 | United States |
| 7 | NCT00103714 (ClinicalTrials.gov) | January 2005 | 14/2/2005 | Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease | A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Cystic Fibrosis Lung Disease | Cystic Fibrosis | Drug: denufosol tetrasodium (INS37217) | Merck Sharp & Dohme Corp. | NULL | Completed | 8 Years | 50 Years | Both | 72 | Phase 2 | United States |
| 8 | NCT00056147 (ClinicalTrials.gov) | April 2003 | 6/3/2003 | Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease | Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of INS37217 Inhalation Solution in Subjects With Mild to Moderate Cystic Fibrosis Lung Disease | Cystic Fibrosis | Drug: denufosol tetrasodium (INS37217) | Merck Sharp & Dohme Corp. | Cystic Fibrosis Foundation Therapeutics | Completed | 8 Years | 50 Years | Both | 90 | Phase 2 | United States |
| 9 | NCT00034515 (ClinicalTrials.gov) | June 2001 | 29/4/2002 | A Study in Adult and Pediatric Patients With Cystic Fibrosis | Ph 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 Patients | Cystic Fibrosis | Drug: denufosol tetrasodium (INS37217) Inhalation Solution | Merck Sharp & Dohme Corp. | NULL | Completed | 5 Years | N/A | Both | 63 | Phase 1;Phase 2 | United States |