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Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00625612
First received: February 12, 2008
Last updated: October 8, 2014
Last verified: October 2014

February 12, 2008
October 8, 2014
February 2008
October 2010   (final data collection date for primary outcome measure)
Change in lung function [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Change in lung function [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00625612 on ClinicalTrials.gov Archive Site
Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease
A Phase 3, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease and FEV1 Greater Than or Equal to 75% Predicted But Less Than or Equal to 110% Predicted

The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but less than or equal to 110% predicted.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cystic Fibrosis
  • Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution
    Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution, Denufosol 60 mg is administered as an inhalation solution, three times daily for twelve months.
  • Drug: Placebo
    Placebo - 0.9% w/v sodium chloride solution, three times daily for twelve months.
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
  • Experimental: 1
    Denufosol Tetrasodium (INS37217) Inhalation Solution
    Intervention: Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution
Ratjen F, Durham T, Navratil T, Schaberg A, Accurso FJ, Wainwright C, Barnes M, Moss RB; TIGER-2 Study Investigator Group. Long term effects of denufosol tetrasodium in patients with cystic fibrosis. J Cyst Fibros. 2012 Dec;11(6):539-49. doi: 10.1016/j.jcf.2012.05.003. Epub 2012 Jun 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
466
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have confirmed diagnosis of cystic fibrosis
  • Have FEV1 of greater than or equal to 75% but less than or equal to 110%predicted normal for age, gender and height
  • Be able to reproducibly perform spirometry
  • Be clinically stable for at least 4 weeks before screening

Exclusion Criteria:

  • Have abnormal renal or liver function
  • Have lung transplant
  • Unable to discontinue use of hypertonic saline
  • Participated in Inspire trial 08-108
Both
5 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   New Zealand
 
NCT00625612
P08640, 08-110
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Principal Investigator: Felix Ratjen, MD, PhD Toronto, Canada
Merck Sharp & Dohme Corp.
October 2014

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