A Study in Pediatric Patients With Cystic Fibrosis Lung Disease

May 21, 2013 updated by: Merck Sharp & Dohme LLC

A Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Pediatric Patients With Cystic Fibrosis Lung Disease

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • The Children's Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • The Minnesota CF Center
      • Minneapolis, Minnesota, United States, 55455
        • General Clinic Research Center University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
respiratory function

Secondary Outcome Measures

Outcome Measure
adverse events
change in standard safety parameters
pulmonary exacerbation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Amy Schaberg, BSN, Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

August 11, 2005

First Submitted That Met QC Criteria

August 11, 2005

First Posted (Estimate)

August 15, 2005

Study Record Updates

Last Update Posted (Estimate)

May 22, 2013

Last Update Submitted That Met QC Criteria

May 21, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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