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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)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00846781
First received: February 18, 2009
Last updated: October 27, 2014
Last verified: October 2014

February 18, 2009
October 27, 2014
February 2009
February 2011   (final data collection date for primary outcome measure)
Rate of change in lung function, as measured by change in FEV1 [ Time Frame: 160 Weeks ] [ Designated as safety issue: No ]
Change in Lung Function [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00846781 on ClinicalTrials.gov Archive Site
  • Change in absolute FEV1 from baseline [ Time Frame: Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160 ] [ Designated as safety issue: No ]
  • Change in FEV1 percent predicted value from baseline [ Time Frame: Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160 ] [ Designated as safety issue: No ]
  • Change in FEF25%-75% and forced vital capacity (FVC) from baseline [ Time Frame: Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160 ] [ Designated as safety issue: No ]
  • Incidence of pulmonary exacerbations [ Time Frame: 160 Weeks ] [ Designated as safety issue: Yes ]
  • Changes in Pseudomonas aeruginosa status [ Time Frame: 160 Weeks ] [ Designated as safety issue: Yes ]
  • Number of days of intravenous (IV) antibiotic use for a respiratory complaint [ Time Frame: 160 Weeks ] [ Designated as safety issue: Yes ]
  • Incidence of hospitalizations/Emergency room (ER) visits for a respiratory complaint [ Time Frame: 160 Weeks ] [ Designated as safety issue: Yes ]
  • Number of days hospitalized for a respiratory complaint [ Time Frame: 160 Weeks ] [ Designated as safety issue: Yes ]
  • Incidence of treatment emergent adverse events (AEs), serious adverse events (SAEs) and withdrawals due to AEs [ Time Frame: 160 Weeks ] [ Designated as safety issue: Yes ]
  • Incidence of patients with significant decrease in absolute FEV1 at any visit from baseline [ Time Frame: 160 Weeks ] [ Designated as safety issue: Yes ]
  • Changes in physical exam findings including height, weight, and body mass index from baseline [ Time Frame: Weeks 48, 96, and 160 ] [ Designated as safety issue: Yes ]
  • Changes in hematology, serum chemistry, and urinalysis parameters from baseline [ Time Frame: Weeks 24, 48, 72, 96, 120, 144, and 160 ] [ Designated as safety issue: Yes ]
  • Incidence of hospitalizations/ER visits [ Time Frame: 160 Weeks ] [ Designated as safety issue: Yes ]
  • Incidence of early discontinuations from the study [ Time Frame: 160 Weeks ] [ Designated as safety issue: Yes ]
Pulmonary exacerbation, antibiotic use, incidence of hospitalizations/ER visits [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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)
Not Provided

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.

Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cystic Fibrosis
Drug: Denufosol tetrasodium Inhalation Solution
60 mg by oral inhalation three times daily
Experimental: Denufosol tetrasodium Inhalation Solution
Intervention: Drug: Denufosol tetrasodium Inhalation Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
308
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
5 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00846781
P08642, 08-114
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Lynn Smiley, MD Medical Monitor
Merck Sharp & Dohme Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP