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)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Terminated
Phase 3

Conditions

Cystic Fibrosis

Treatments

Drug: Denufosol tetrasodium Inhalation Solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT00846781
08-114
P08642

Details and patient eligibility

About

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.

Enrollment

308 patients

Sex

All

Ages

5+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

308 participants in 1 patient group

Denufosol tetrasodium Inhalation Solution
Experimental group
Treatment:
Drug: Denufosol tetrasodium Inhalation Solution

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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