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A Safety and Tolerability Study of Denufosol in 2-4 Year Olds (REACH-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01181622
Recruitment Status : Completed
First Posted : August 13, 2010
Last Update Posted : January 13, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE August 12, 2010
First Posted Date  ICMJE August 13, 2010
Last Update Posted Date January 13, 2015
Study Start Date  ICMJE August 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2010)
Intolerability to study drug as measured by: oxyhemoglobin saturation, treatment-emergent cough, and new wheezes or crackles [ Time Frame: Day 1, Day 7 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2010)
  • Mean change from pre-dose in oxyhemoglobin saturation at defined times post-dose [ Time Frame: Day 1, Day 7 ]
  • Mean change from baseline in oxyhemoglobin saturation [ Time Frame: Day 7 ]
  • Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and/or withdrawals due to TEAEs [ Time Frame: Day 7 ]
  • Mean change from pre-dose in pulse and respiratory rate at defined times post-dose [ Time Frame: Day 1, Day 7 ]
  • Mean change from baseline in pulse and respiratory rate [ Time Frame: Day 7 ]
  • Incidence of new medical condition(s) or worsening of previous medical condition(s) from baseline [ Time Frame: Day 7 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Tolerability Study of Denufosol in 2-4 Year Olds
Official Title  ICMJE A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 7-Day Safety and Tolerability Study of Denufosol Tetrasodium Inhalation Solution Administered Via PARI LC® Star in Patients 2 to 4 Years of Age With Cystic Fibrosis
Brief Summary The purpose of this study is to evaluate the safety and tolerability of denufosol 60 mg TID in pediatric CF patients 2 to 4 years of age
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE
  • Drug: denufosol tetrasodium Inhalation Solution
    60 mg by oral inhalation three times daily
  • Drug: 0.9% w/v sodium chloride solution
    0.9% w/v sodium chloride solution by oral inhalation three times daily
Study Arms  ICMJE
  • Experimental: denufosol tetrasodium Inhalation Solution
    Intervention: Drug: denufosol tetrasodium Inhalation Solution
  • Placebo Comparator: Placebo
    Intervention: Drug: 0.9% w/v sodium chloride 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 Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2010)
25
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2010)
24
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a confirmed diagnosis of CF
  • Have oxyhemoglobin saturation ≥ 95% prior to randomization

Exclusion Criteria:

  • Have acute intercurrent respiratory infection (cough, wheezing, or new

rhinorrhea or nasal congestion)

  • Have any significant medical condition not related to CF
  • Unable to discontinue use of hypertonic saline
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 4 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01181622
Other Study ID Numbers  ICMJE P08643
08-116
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account Merck Sharp & Dohme Corp.
Verification Date December 2014

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