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A Study in Pediatric Patients With Cystic Fibrosis Lung Disease

This study has been completed.
Information provided by:
Merck Sharp & Dohme Corp. Identifier:
First received: August 11, 2005
Last updated: May 21, 2013
Last verified: May 2013
The purpose of this study is to investigate the safety and effectiveness of two dose strengths of study drug compared to placebo in pediatric patients with cystic fibrosis (CF).

Condition Intervention Phase
Cystic Fibrosis Drug: denufosol tetrasodium (INS37217) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Pediatric Patients With Cystic Fibrosis Lung Disease

Resource links provided by NLM:

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

Primary Outcome Measures:
  • respiratory function

Secondary Outcome Measures:
  • adverse events
  • change in standard safety parameters
  • pulmonary exacerbation

Enrollment: 13
Study Start Date: August 2005
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have confirmed diagnosis of CF
  • Have an FEV1 greater than or equal to 60%
  • Have oxygen saturation greater than or equal to 90% on room air
  • Be clinically stable for at least 4 weeks prior to screening
  • Be able to reproducibly perform spirometry maneuvers

Exclusion Criteria:

  • Have clinically significant comorbidities
  • Have changed their physiotherapy technique or schedule within 7 days prior to screening
  • Using prior and concurrent medications according to protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00130182

United States, Colorado
The Children's Hospital
Denver, Colorado, United States, 80218
United States, Minnesota
General Clinic Research Center University of Minnesota
Minneapolis, Minnesota, United States, 55455
The Minnesota CF Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Amy Schaberg, BSN Merck Sharp & Dohme Corp.
  More Information Identifier: NCT00130182     History of Changes
Other Study ID Numbers: 08-107
Study First Received: August 11, 2005
Last Updated: May 21, 2013

Keywords provided by Merck Sharp & Dohme Corp.:
lung disease

Additional relevant MeSH terms:
Cystic Fibrosis
Lung Diseases
Pulmonary Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases processed this record on September 21, 2017