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

NCT01181622 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-01-13

No results posted yet for this study

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

Conditions

Interventions

DRUG

denufosol tetrasodium Inhalation Solution

60 mg by oral inhalation three times daily

DRUG

0.9% w/v sodium chloride solution

0.9% w/v sodium chloride solution by oral inhalation three times daily

Sponsors & Collaborators

Principal Investigators

  • Lynn Smiley, MD · Medical monitor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2010-10-31
Completion
2010-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01181622 on ClinicalTrials.gov