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A Study in Pediatric Patients With Cystic Fibrosis Lung Disease

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00130182
First received: August 11, 2005
Last updated: October 18, 2007
Last verified: October 2007
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

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

Further study details as provided by Merck:

Primary Outcome Measures:
  • respiratory function

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

Enrollment: 13
Study Start Date: August 2005
  Eligibility

Ages Eligible for Study:   5 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130182

Locations
United States, Colorado
The Children's Hospital
Denver, Colorado, United States, 80218
United States, Minnesota
The Minnesota CF Center
Minneapolis, Minnesota, United States, 55455
General Clinic Research Center University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Merck
Investigators
Study Director: Amy Schaberg, BSN Merck
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00130182     History of Changes
Other Study ID Numbers: 08-107
Study First Received: August 11, 2005
Last Updated: October 18, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
lung disease

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

ClinicalTrials.gov processed this record on May 16, 2013