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A Study in Pediatric Patients With Cystic Fibrosis Lung Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00130182
First Posted: August 15, 2005
Last Update Posted: May 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Merck Sharp & Dohme Corp.
August 11, 2005
August 15, 2005
May 22, 2013
August 2005
September 2006   (Final data collection date for primary outcome measure)
respiratory function
Same as current
Complete list of historical versions of study NCT00130182 on ClinicalTrials.gov Archive Site
  • adverse events
  • change in standard safety parameters
  • pulmonary exacerbation
Same as current
Not Provided
Not Provided
 
A Study in Pediatric Patients With Cystic Fibrosis Lung Disease
A Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Pediatric Patients With Cystic Fibrosis Lung Disease
The purpose of this study is to investigate the safety and effectiveness of two dose strengths of study drug compared to placebo in pediatric patients with cystic fibrosis (CF).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Cystic Fibrosis
Drug: denufosol tetrasodium (INS37217)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
Not Provided
September 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have confirmed diagnosis of CF
  • 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 clinically significant comorbidities
  • Have changed their physiotherapy technique or schedule within 7 days prior to screening
  • Using prior and concurrent medications according to protocol
Sexes Eligible for Study: All
5 Years to 7 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00130182
08-107
Not Provided
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Amy Schaberg, BSN Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP