Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease
This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: February 14, 2005
Last updated: November 15, 2013
Last verified: November 2013
The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease.
Drug: denufosol tetrasodium (INS37217)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Cystic Fibrosis Lung Disease
Primary Outcome Measures:
Secondary Outcome Measures:
- adverse events
- change in standard safety parameters
- respiratory symptoms via questionnaire
- pulmonary exacerbation
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2005 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||8 Years to 50 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Have confirmed diagnosis of CF
- Have an FEV1 greater than or equal to 60% or less than or equal to 90% of predicted normal
- Have oxygen saturation greater than or equal to 90% on room air
- Be clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation
- Be able to reproducibly perform spirometry maneuvers
- Have changed their physiotherapy technique or schedule within 7 days prior to screening
- Have clinically significant comorbidities
- Using prior and concurrent medications according to the protocol
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103714
Merck Sharp & Dohme Corp.
||Amy Schaberg, BSN
No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 14, 2005
||November 15, 2013
||United States: Food and Drug Administration
Keywords provided by Merck Sharp & Dohme Corp.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases