NCT00130182

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Last Updated

May 22, 2013

Status Verified

May 1, 2013

Enrollment Period

1.1 years

First QC Date

August 11, 2005

Last Update Submit

May 21, 2013

Conditions

Cystic Fibrosis

Keywords

lung disease

Outcome Measures

Primary Outcomes (1)

  • respiratory function

Secondary Outcomes (3)

  • adverse events

  • change in standard safety parameters

  • pulmonary exacerbation

Interventions

denufosol tetrasodium (INS37217)DRUG

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Children's Hospital

Denver, Colorado, 80218, United States

Location

General Clinic Research Center University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

The Minnesota CF Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Cystic FibrosisLung Diseases

Interventions

denufosol tetrasodium

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Amy Schaberg, BSN

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 11, 2005

First Posted

August 15, 2005

Study Start

August 1, 2005

Primary Completion

September 1, 2006

Last Updated

May 22, 2013

Record last verified: 2013-05

Locations

US(3)