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Main
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Note: This record shows only the 20 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01181622 |
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Date of registration:
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12/08/2010 |
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Primary sponsor: |
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Public title:
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A Safety and Tolerability Study of Denufosol in 2-4 Year Olds
REACH-1 |
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Scientific title:
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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 LC® Star in Patients 2 to 4 Years of Age With Cystic Fibrosis |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01181622 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Lynn Smiley, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical monitor |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: 0.9% w/v sodium chloride solution
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Drug: denufosol tetrasodium Inhalation Solution
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Primary Outcome(s)
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Intolerability to study drug as measured by: oxyhemoglobin saturation, treatment-emergent cough, and new wheezes or crackles
[Time Frame: Day 1, Day 7]
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Secondary Outcome(s)
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Incidence of new medical condition(s) or worsening of previous medical condition(s) from baseline
[Time Frame: Day 7]
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Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and/or withdrawals due to TEAEs
[Time Frame: Day 7]
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Mean change from baseline in oxyhemoglobin saturation
[Time Frame: Day 7]
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Mean change from baseline in pulse and respiratory rate
[Time Frame: Day 7]
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Mean change from pre-dose in oxyhemoglobin saturation at defined times post-dose
[Time Frame: Day 1, Day 7]
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Mean change from pre-dose in pulse and respiratory rate at defined times post-dose
[Time Frame: Day 1, Day 7]
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Secondary ID(s)
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08-116
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P08643
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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