Back to resultsA Study in Pediatric Patients With Cystic Fibrosis Lung Disease
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
denufosol tetrasodium (INS37217)
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring lung disease
Eligibility Criteria
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
Sites / Locations
- The Children's Hospital
- General Clinic Research Center University of Minnesota
- The Minnesota CF Center
Outcomes
Primary Outcome Measures
respiratory function
Secondary Outcome Measures
adverse events
change in standard safety parameters
pulmonary exacerbation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00130182
Brief Title
A Study in Pediatric Patients With Cystic Fibrosis Lung Disease
Official Title
A Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Pediatric Patients With Cystic Fibrosis Lung Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
lung disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
denufosol tetrasodium (INS37217)
Primary Outcome Measure Information:
Title
respiratory function
Secondary Outcome Measure Information:
Title
adverse events
Title
change in standard safety parameters
Title
pulmonary exacerbation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Schaberg, BSN
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
The Children's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
General Clinic Research Center University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
The Minnesota CF Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study in Pediatric Patients With Cystic Fibrosis Lung Disease
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