A Safety and Tolerability Study of Denufosol in 2-4 Year... | NCT01181622

Studies
A Safety and Tolerability Study of Denufosol in 2-4 Year Olds

NCT01181622

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Jan 13, 2015Estimated

Enrollment

25Actual

Phase

Phase 2

Conditions

Cystic Fibrosis

Interventions

denufosol tetrasodium Inhalation Solution
0.9% w/v sodium chloride solution

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

ID	Type	Description	Link
08-116

Official Title

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 7-Day Safety and Tolerability Study of Denufosol Tetrasodium Inhalation Solution Administered Via PARI LC® Star in Patients 2 to 4 Years of Age With Cystic Fibrosis

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Aug 12, 2010

First Submission Date that Met QC Criteria

Aug 12, 2010

First Posted Date

Aug 13, 2010Estimated

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

Mar 24, 2011

Certification/Extension First Submitted that Passed QC Review

Mar 30, 2011

Certification/Extension First Posted Date

Apr 7, 2011Estimated

Last Update Submitted Date

Dec 29, 2014

Last Update Posted Date

Jan 13, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of denufosol 60 mg TID in pediatric CF patients 2 to 4 years of age

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

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
denufosol tetrasodium Inhalation Solution	Experimental		Drug: denufosol tetrasodium Inhalation Solution
Placebo	Placebo Comparator		Drug: 0.9% w/v sodium chloride solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
denufosol tetrasodium Inhalation Solution	Drug	60 mg by oral inhalation three times daily	denufosol tetrasodium Inhalation Solution

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intolerability to study drug as measured by: oxyhemoglobin saturation, treatment-emergent cough, and new wheezes or crackles		Day 1, Day 7

Secondary Outcomes

Measure	Description	Time Frame
Mean change from pre-dose in oxyhemoglobin saturation at defined times post-dose		Day 1, Day 7
Mean change from baseline in oxyhemoglobin saturation		Day 7

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have a confirmed diagnosis of CF
Have oxyhemoglobin saturation ≥ 95% prior to randomization

Exclusion Criteria:

Have acute intercurrent respiratory infection (cough, wheezing, or new

rhinorrhea or nasal congestion)

Have any significant medical condition not related to CF
Unable to discontinue use of hypertonic saline

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

4 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lynn Smiley, MD	Medical monitor	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided