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Controlled Study of ONO-5046Na in Patients With Acute Respiratory Failure Associated With Community-Acquired Pneumonia

Primary Purpose

Community-acquired Pneumonia

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
ONO-5046Na
ONO-5046Na
Sponsored by
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community-acquired Pneumonia focused on measuring ONO-5046Na, acute respiratory failure, community-acquired pneumonia

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with nosocomial pneumonia
  • Patients on mechanical ventilation

Sites / Locations

  • Chubu Region
  • Chugoku Region
  • Hokkaido Region
  • Hokuriku Region
  • Kanto Region
  • Kinki Region
  • Kyushu Region
  • Shikoku Region
  • Tohoku Region

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

P

E

Arm Description

Outcomes

Primary Outcome Measures

pulmonary function

Secondary Outcome Measures

mortality
ventilator status

Full Information

First Posted
December 28, 2006
Last Updated
June 12, 2012
Sponsor
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00417326
Brief Title
Controlled Study of ONO-5046Na in Patients With Acute Respiratory Failure Associated With Community-Acquired Pneumonia
Official Title
ONO-5046Na Phase II Study - A Pilot Study for Patients With Acute Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
Keywords
ONO-5046Na, acute respiratory failure, community-acquired pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P
Arm Type
Placebo Comparator
Arm Title
E
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ONO-5046Na
Intervention Description
twenty four hour infusion at 0 mg/kg/hr for 14 days
Intervention Type
Drug
Intervention Name(s)
ONO-5046Na
Intervention Description
twenty four hour intravenous infusion at 0.2 mg/kg/hr for 14 days
Primary Outcome Measure Information:
Title
pulmonary function
Time Frame
14 days
Secondary Outcome Measure Information:
Title
mortality
Time Frame
28 days
Title
ventilator status
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with community-acquired pneumonia Patients with acute respiratory failure Exclusion Criteria: Patients with nosocomial pneumonia Patients on mechanical ventilation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koji Takehara
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Chubu Region
City
Chubu
Country
Japan
Facility Name
Chugoku Region
City
Chugoku
Country
Japan
Facility Name
Hokkaido Region
City
Hokkaido
Country
Japan
Facility Name
Hokuriku Region
City
Hokuriku
Country
Japan
Facility Name
Kanto Region
City
Kanto
Country
Japan
Facility Name
Kinki Region
City
Kinki
Country
Japan
Facility Name
Kyushu Region
City
Kyushu
Country
Japan
Facility Name
Shikoku Region
City
Shikoku
Country
Japan
Facility Name
Tohoku Region
City
Tohuku
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Controlled Study of ONO-5046Na in Patients With Acute Respiratory Failure Associated With Community-Acquired Pneumonia

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