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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01181622
First received: August 12, 2010
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

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

Enrollment: 25
Study Start Date: August 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years to 4 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181622

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01181622     History of Changes
Other Study ID Numbers: P08643, 08-116
Study First Received: August 12, 2010
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014