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A Study in Pediatric Patients With Cystic Fibrosis Lung Disease

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ClinicalTrials.gov Identifier: NCT00130182
Recruitment Status : Completed
First Posted : August 15, 2005
Last Update Posted : May 22, 2013
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Cystic Fibrosis Drug: denufosol tetrasodium (INS37217) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
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
Study Start Date : August 2005
Primary Completion Date : September 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. respiratory function

Secondary Outcome Measures :
  1. adverse events
  2. change in standard safety parameters
  3. pulmonary exacerbation

Eligibility Criteria

Information from the National Library of Medicine

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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

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): 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

ClinicalTrials.gov Identifier: NCT00130182     History of Changes
Other Study ID Numbers: 08-107
First Posted: August 15, 2005    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: May 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