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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00846781 |
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Date of registration:
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18/02/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study 08-114 Open-label Extension of Study 08-110 - A Multi-Center Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease (P08642)
DEFY |
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Scientific title:
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Date of first enrolment:
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February 2009 |
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Target sample size:
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308 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00846781 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Canada
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New Zealand
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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:
- Completed Study 08-110
Exclusion Criteria:
- A female patient will not be eligible for the study if she is of childbearing
potential and is pregnant, lactating, and/or not practicing an acceptable method of
birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization,
or intrauterine device).
- Have a condition that might affect compliance with study procedures
Age minimum:
5 Years
Age maximum:
N/A
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: Denufosol tetrasodium Inhalation Solution
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Primary Outcome(s)
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Rate of change in lung function, as measured by change in FEV1
[Time Frame: 160 Weeks]
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Secondary Outcome(s)
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Incidence of early discontinuations from the study
[Time Frame: 160 Weeks]
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Incidence of pulmonary exacerbations
[Time Frame: 160 Weeks]
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Changes in hematology, serum chemistry, and urinalysis parameters from baseline
[Time Frame: Weeks 24, 48, 72, 96, 120, 144, and 160]
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Change in FEF25%-75% and forced vital capacity (FVC) from baseline
[Time Frame: Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160]
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Change in absolute FEV1 from baseline
[Time Frame: Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160]
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Incidence of hospitalizations/Emergency room (ER) visits for a respiratory complaint
[Time Frame: 160 Weeks]
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Number of days hospitalized for a respiratory complaint
[Time Frame: 160 Weeks]
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Number of days of intravenous (IV) antibiotic use for a respiratory complaint
[Time Frame: 160 Weeks]
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Change in FEV1 percent predicted value from baseline
[Time Frame: Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160]
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Incidence of patients with significant decrease in absolute FEV1 at any visit from baseline
[Time Frame: 160 Weeks]
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Incidence of hospitalizations/ER visits
[Time Frame: 160 Weeks]
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Changes in physical exam findings including height, weight, and body mass index from baseline
[Time Frame: Weeks 48, 96, and 160]
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Changes in Pseudomonas aeruginosa status
[Time Frame: 160 Weeks]
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Incidence of treatment emergent adverse events (AEs), serious adverse events (SAEs) and withdrawals due to AEs
[Time Frame: 160 Weeks]
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Secondary ID(s)
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P08642
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08-114
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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