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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 18, 2009

Last Updated Date

October 27, 2014

Start Date ^ICMJE

February 2009

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change in Lung Function [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00846781 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Pulmonary exacerbation, antibiotic use, incidence of hospitalizations/ER visits [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

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: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cystic Fibrosis

Intervention ^ICMJE

Drug: Denufosol tetrasodium Inhalation Solution

60 mg by oral inhalation three times daily

Study Arm (s)

Experimental: Denufosol tetrasodium Inhalation Solution

Intervention: Drug: Denufosol tetrasodium Inhalation Solution

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

308

Completion Date

February 2011

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

5 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

United States, Australia, Canada, New Zealand

Administrative Information

NCT Number ^ICMJE

NCT00846781

Other Study ID Numbers ^ICMJE

P08642, 08-114

Has Data Monitoring Committee

Yes

Responsible Party

Merck Sharp & Dohme Corp.

Study Sponsor ^ICMJE

Merck Sharp & Dohme Corp.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Lynn Smiley, MD

Medical Monitor

Information Provided By

Merck Sharp & Dohme Corp.

Verification Date

October 2014

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

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