Cystic Fibrosis Clinical Trial
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
NCT number | NCT00130182 |
Other study ID # | 08-107 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | August 11, 2005 |
Last updated | May 21, 2013 |
Start date | August 2005 |
Verified date | May 2013 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 13 |
Est. completion date | |
Est. primary completion date | September 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 5 Years to 7 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | 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 |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | respiratory function | |||
Secondary | adverse events | |||
Secondary | change in standard safety parameters | |||
Secondary | pulmonary exacerbation |
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