A Study in Pediatric Patients With Cystic Fibrosis Lung D... | NCT00130182

Studies
A Study in Pediatric Patients With Cystic Fibrosis Lung Disease

NCT00130182

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

May 22, 2013Estimated

Enrollment

13Actual

Phase

Phase 2

Conditions

Cystic Fibrosis

Interventions

denufosol tetrasodium (INS37217)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Aug 2005

Primary Completion Date

Sep 2006Actual

Completion Date

Not provided

First Submitted Date

Aug 11, 2005

First Submission Date that Met QC Criteria

Aug 11, 2005

First Posted Date

Aug 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2013

Last Update Posted Date

May 22, 2013Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Name	Type	Description	Arm Group Labels	Other Names
denufosol tetrasodium (INS37217)	Drug

Measure	Description	Time Frame
respiratory function

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

7 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amy Schaberg, BSN	Merck Sharp & Dohme LLC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Children's Hospital		Denver	Colorado	80218	United States
General Clinic Research Center University of Minnesota

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis
D008171	Lung Diseases

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D012140	Respiratory Tract Diseases
D030342	Genetic Diseases, Inborn

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C465279	denufosol tetrasodium

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
adverse events
change in standard safety parameters
pulmonary exacerbation