Status:
COMPLETED
A Safety and Tolerability Study of Denufosol in 2-4 Year Olds
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
2-4 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of denufosol 60 mg TID in pediatric CF patients 2 to 4 years of age
Eligibility Criteria
Inclusion
- Have a confirmed diagnosis of CF
- Have oxyhemoglobin saturation ≥ 95% prior to randomization
Exclusion
- Have acute intercurrent respiratory infection (cough, wheezing, or new
- rhinorrhea or nasal congestion)
- Have any significant medical condition not related to CF
- Unable to discontinue use of hypertonic saline
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01181622
Start Date
August 1 2010
End Date
October 1 2010
Last Update
January 13 2015
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