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

NCT ID: NCT01181622

Last Updated: 2015-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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denufosol tetrasodium Inhalation Solution

Group Type EXPERIMENTAL

denufosol tetrasodium Inhalation Solution

Intervention Type DRUG

60 mg by oral inhalation three times daily

Placebo

Group Type PLACEBO_COMPARATOR

0.9% w/v sodium chloride solution

Intervention Type DRUG

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

Interventions

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denufosol tetrasodium Inhalation Solution

60 mg by oral inhalation three times daily

Intervention Type DRUG

0.9% w/v sodium chloride solution

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have a confirmed diagnosis of CF
* Have oxyhemoglobin saturation ≥ 95% prior to randomization

Exclusion Criteria

* 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
Minimum Eligible Age

2 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lynn Smiley, MD

Role: STUDY_DIRECTOR

Medical monitor

Other Identifiers

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08-116

Identifier Type: -

Identifier Source: secondary_id

P08643

Identifier Type: -

Identifier Source: org_study_id

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