NCT00417326

Brief Summary

The purpose of this study is to determine the safety and efficacy of ONO-5046Na in patients with acute respiratory failure associated with community-acquired pneumonia

Trial Health

80
On Track

Trial Health Score

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

Enrollment
174

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

9 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

December 1, 2006

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 1, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

Enrollment Period

2.7 years

First QC Date

December 28, 2006

Last Update Submit

June 12, 2012

Conditions

Community-acquired Pneumonia

Keywords

ONO-5046Naacute respiratory failurecommunity-acquired pneumonia

Outcome Measures

Primary Outcomes (1)

  • pulmonary function

    14 days

Secondary Outcomes (2)

  • mortality

    28 days

  • ventilator status

    28 days

Study Arms (2)

P

PLACEBO COMPARATOR
Drug: ONO-5046Na

E

EXPERIMENTAL
Drug: ONO-5046Na

Interventions

ONO-5046NaDRUG

twenty four hour infusion at 0 mg/kg/hr for 14 days

P

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with community-acquired pneumonia
  • Patients with acute respiratory failure

You may not qualify if:

  • Patients with nosocomial pneumonia
  • Patients on mechanical ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Chugoku Region

Chugoku, Japan

Location

Chubu Region

Chūbu, Japan

Location

Hokkaido Region

Hokkaido, Japan

Location

Hokuriku Region

Hokuriku, Japan

Location

Kanto Region

Kanto, Japan

Location

Kinki Region

Kinki, Japan

Location

Kyushu Region

Kyushu, Japan

Location

Shikoku Region

Shikoku, Japan

Location

Tohoku Region

Tohuku, Japan

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Koji Takehara

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2006

First Posted

January 1, 2007

Study Start

December 1, 2006

Primary Completion

August 1, 2009

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations

JP(9)