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

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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.

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

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: denufosol tetrasodium Inhalation Solution Drug: 0.9% w/v sodium chloride solution Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: denufosol tetrasodium Inhalation Solution Drug: denufosol tetrasodium Inhalation Solution
60 mg by oral inhalation three times daily
Placebo Comparator: Placebo Drug: 0.9% w/v sodium chloride solution
0.9% w/v sodium chloride solution by oral inhalation three times daily



Primary Outcome Measures :
  1. Intolerability to study drug as measured by: oxyhemoglobin saturation, treatment-emergent cough, and new wheezes or crackles [ Time Frame: Day 1, Day 7 ]

Secondary Outcome Measures :
  1. Mean change from pre-dose in oxyhemoglobin saturation at defined times post-dose [ Time Frame: Day 1, Day 7 ]
  2. Mean change from baseline in oxyhemoglobin saturation [ Time Frame: Day 7 ]
  3. Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and/or withdrawals due to TEAEs [ Time Frame: Day 7 ]
  4. Mean change from pre-dose in pulse and respiratory rate at defined times post-dose [ Time Frame: Day 1, Day 7 ]
  5. Mean change from baseline in pulse and respiratory rate [ Time Frame: Day 7 ]
  6. Incidence of new medical condition(s) or worsening of previous medical condition(s) from baseline [ Time Frame: Day 7 ]


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Ages Eligible for Study:   2 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181622


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Lynn Smiley, MD Medical monitor

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01181622     History of Changes
Other Study ID Numbers: P08643
08-116
First Posted: August 13, 2010    Key Record Dates
Last Update Posted: January 13, 2015
Last Verified: December 2014

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pharmaceutical Solutions