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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A Safety and Tolerability Study of Denufosol in 2-4 Year Olds | DecenTrialz