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A Study in Pediatric Patients With Cystic Fibrosis Lung Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00130182
First Posted: August 15, 2005
Last Update Posted: May 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Merck Sharp & Dohme Corp.
  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
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)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
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
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


Locations
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.
Investigators
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 Submitted: August 11, 2005
First Posted: August 15, 2005
Last Update Posted: May 22, 2013
Last Verified: May 2013

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

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