Pulmozyme (dornase alfa) (DrugBank: Dornase alfa)
2 diseases告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
53 | シェーグレン症候群 | 0 |
299 | 嚢胞性線維症 | 3 |
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 |
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1 | NCT01712334 (ClinicalTrials.gov) | December 2012 | 19/10/2012 | A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis | A Phase IV Multicenter, Randomized, Open Label, Two-Period, Crossover Study in Patients With Cystic Fibrosis to Evaluate the Comparable Efficacy and Safety of Pulmozyme Delivered by the eRapid Nebulizer System | Cystic Fibrosis | Drug: dornase alfa [Pulmozyme®] | Genentech, Inc. | NULL | Completed | 6 Years | N/A | All | 99 | Phase 4 | United States |
2 | NCT00416182 (ClinicalTrials.gov) | December 2006 | 26/12/2006 | Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis | The Use of Nasally Delivered Pulmozyme in the Treatment of Sinusitis in Cystic Fibrosis Patients: A Pilot Study | Sinusitis;Cystic Fibrosis | Drug: Pulmozyme (dornase alfa);Drug: Placebo | University of Vermont | Genentech, Inc. | Completed | 5 Years | N/A | All | 16 | Phase 2 | United States |
3 | EUCTR2015-003537-99-Outside-EU/EEA (EUCTR) | 05/07/2016 | A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis | A PHASE IV MULTICENTER, RANDOMIZED, OPEN LABEL, TWO-PERIOD CROSSOVER STUDY IN PATIENTS WITH CYSTIC FIBROSIS TO EVALUATE THE COMPARABLE EFFICACY AND SAFETY OF PULMOZYME® DELIVERED BY THE ERAPID™ NEBULIZER SYSTEM | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Pulmozyme Product Name: Pulmozyme INN or Proposed INN: DORNASE ALFA | F. Hoffmann-La Roche AG | NULL | NA | Female: yes Male: yes | 80 | Phase 4 | United States |