A Phase 3 interventional study of Denufosol Tetrasodium (INS37217) Inhalation Solution and Placebo in Cystic Fibrosis, sponsored by Merck Sharp & Dohme LLC. Completed at 106 sites in 4 countries. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2015-11-01.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment
The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but less than or equal to 110% predicted.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 466 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
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Exclusion Criteria:
Drug: Placebo
Denufosol Tetrasodium (INS37217) Inhalation Solution
Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution
Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution, Denufosol 60 mg is administered as an inhalation solution, three times daily for twelve months.
Placebo - 0.9% w/v sodium chloride solution, three times daily for twelve months.
Change in lung function
Time frame: 48 weeks
Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life
Time frame: 48 weeks
Showing the first 100 of 106 sites across 4 countries.
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC