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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ClinicalTrials.gov Identifier: NCT00846781 |
Recruitment Status
:
Terminated
First Posted
: February 19, 2009
Last Update Posted
: November 6, 2015
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Tracking Information | ||||
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First Submitted Date ICMJE | February 18, 2009 | |||
First Posted Date ICMJE | February 19, 2009 | |||
Last Update Posted Date | November 6, 2015 | |||
Study Start Date ICMJE | February 2009 | |||
Actual Primary Completion Date | February 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Rate of change in lung function, as measured by change in FEV1 [ Time Frame: 160 Weeks ] | |||
Original Primary Outcome Measures ICMJE |
Change in Lung Function [ Time Frame: 48 weeks ] | |||
Change History | Complete list of historical versions of study NCT00846781 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Pulmonary exacerbation, antibiotic use, incidence of hospitalizations/ER visits [ Time Frame: 48 weeks ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | 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) | |||
Official Title ICMJE | Not Provided | |||
Brief Summary | The purpose of this study is to obtain data on the potential of long-term treatment with denufosol to improve the clinical course of CF lung disease in patients with mildly impaired lung function and to provide CF patients who completed study 08-110 continued access to denufosol. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Cystic Fibrosis | |||
Intervention ICMJE | Drug: Denufosol tetrasodium Inhalation Solution
60 mg by oral inhalation three times daily |
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Study Arms | Experimental: Denufosol tetrasodium Inhalation Solution
Intervention: Drug: Denufosol tetrasodium Inhalation Solution |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
308 | |||
Original Estimated Enrollment ICMJE |
380 | |||
Actual Study Completion Date | February 2011 | |||
Actual Primary Completion Date | February 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 5 Years and older (Child, Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | Australia, Canada, New Zealand, United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00846781 | |||
Other Study ID Numbers ICMJE | P08642 08-114 |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Merck Sharp & Dohme Corp. | |||
Study Sponsor ICMJE | Merck Sharp & Dohme Corp. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Merck Sharp & Dohme Corp. | |||
Verification Date | October 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |