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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01181622
Date of registration: 12/08/2010
Prospective Registration: Yes
Primary sponsor: Merck Sharp & Dohme Corp.
Public title: A Safety and Tolerability Study of Denufosol in 2-4 Year Olds REACH-1
Scientific title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 7-Day Safety and Tolerability Study of Denufosol Tetrasodium Inhalation Solution Administered Via PARI LCĀ® Star in Patients 2 to 4 Years of Age With Cystic Fibrosis
Date of first enrolment: August 2010
Target sample size: 25
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01181622
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Lynn Smiley, MD
Address: 
Telephone:
Email:
Affiliation:  Medical monitor
Key inclusion & exclusion criteria

Inclusion Criteria:

- Have a confirmed diagnosis of CF

- Have oxyhemoglobin saturation = 95% prior to randomization

Exclusion Criteria:

- Have acute intercurrent respiratory infection (cough, wheezing, or new

rhinorrhea or nasal congestion)

- Have any significant medical condition not related to CF

- Unable to discontinue use of hypertonic saline



Age minimum: 2 Years
Age maximum: 4 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Cystic Fibrosis
Intervention(s)
Drug: 0.9% w/v sodium chloride solution
Drug: denufosol tetrasodium Inhalation Solution
Primary Outcome(s)
Intolerability to study drug as measured by: oxyhemoglobin saturation, treatment-emergent cough, and new wheezes or crackles [Time Frame: Day 1, Day 7]
Secondary Outcome(s)
Incidence of new medical condition(s) or worsening of previous medical condition(s) from baseline [Time Frame: Day 7]
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and/or withdrawals due to TEAEs [Time Frame: Day 7]
Mean change from baseline in oxyhemoglobin saturation [Time Frame: Day 7]
Mean change from baseline in pulse and respiratory rate [Time Frame: Day 7]
Mean change from pre-dose in oxyhemoglobin saturation at defined times post-dose [Time Frame: Day 1, Day 7]
Mean change from pre-dose in pulse and respiratory rate at defined times post-dose [Time Frame: Day 1, Day 7]
Secondary ID(s)
08-116
P08643
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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