Study of Denufosol Tetrasodium in Patients With Cystic Fi... | NCT00103714

Studies
Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease

NCT00103714

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Oct 20, 2015Estimated

Enrollment

72Actual

Phase

Phase 2

Conditions

Cystic Fibrosis

Interventions

denufosol tetrasodium (INS37217)

Countries

Not provided

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

Oct 2015

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

Jan 2005

Primary Completion Date

Aug 2005Actual

Completion Date

Aug 2005Actual

First Submitted Date

Feb 14, 2005

First Submission Date that Met QC Criteria

Feb 14, 2005

First Posted Date

Feb 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

Oct 19, 2015

Last Update Posted Date

Oct 20, 2015Estimated

Description Module

Brief Summary

The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease.

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

72Actual

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
respiratory function

Secondary Outcomes

Measure	Description	Time Frame
adverse events
change in standard safety parameters
respiratory symptoms via questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have confirmed diagnosis of CF
Have an FEV1 greater than or equal to 60% or less than or equal to 90% of predicted normal
Have oxygen saturation greater than or equal to 90% on room air
Be clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation
Be able to reproducibly perform spirometry maneuvers

Exclusion Criteria:

Have changed their physiotherapy technique or schedule within 7 days prior to screening
Have clinically significant comorbidities
Using prior and concurrent medications according to the protocol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Amy Schaberg, BSN		Study Director

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