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: May 21, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 11, 2005

Last Updated Date

May 21, 2013

Start Date ^ICMJE

August 2005

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

respiratory function

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00130182 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

adverse events
change in standard safety parameters
pulmonary exacerbation

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study in Pediatric Patients With Cystic Fibrosis Lung Disease

Official Title ^ICMJE

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

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Cystic Fibrosis

Intervention ^ICMJE

Drug: denufosol tetrasodium (INS37217)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

5 Years to 7 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00130182

Other Study ID Numbers ^ICMJE

08-107

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amy Schaberg, BSN

Merck

Information Provided By

Merck

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top