A Study in Pediatric Patients With Cystic Fibrosis Lung Disease
NCT ID: NCT00130182
Last Updated: 2013-05-22
Study Results
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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COMPLETED
PHASE2
13 participants
INTERVENTIONAL
2005-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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denufosol tetrasodium (INS37217)
Eligibility Criteria
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Inclusion Criteria
* Have an FEV1 greater than or equal to 60%
* Have oxygen saturation greater than or equal to 90% on room air
* Be clinically stable for at least 4 weeks prior to screening
* Be able to reproducibly perform spirometry maneuvers
Exclusion Criteria
* Have changed their physiotherapy technique or schedule within 7 days prior to screening
* Using prior and concurrent medications according to protocol
5 Years
7 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Principal Investigators
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Amy Schaberg, BSN
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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The Children's Hospital
Denver, Colorado, United States
General Clinic Research Center University of Minnesota
Minneapolis, Minnesota, United States
The Minnesota CF Center
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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08-107
Identifier Type: -
Identifier Source: org_study_id
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