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

NCT ID: NCT00417326

Last Updated: 2012-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Community-acquired Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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P

Group Type PLACEBO_COMPARATOR

ONO-5046Na

Intervention Type DRUG

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

E

Group Type EXPERIMENTAL

ONO-5046Na

Intervention Type DRUG

twenty four hour intravenous infusion at 0.2 mg/kg/hr for 14 days

Interventions

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ONO-5046Na

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

Intervention Type DRUG

ONO-5046Na

twenty four hour intravenous infusion at 0.2 mg/kg/hr for 14 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with nosocomial pneumonia
* Patients on mechanical ventilation
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Koji Takehara

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

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Chugoku Region

Chugoku, , Japan

Site Status

Chubu Region

Chūbu, , Japan

Site Status

Hokkaido Region

Hokkaido, , Japan

Site Status

Hokuriku Region

Hokuriku, , Japan

Site Status

Kanto Region

Kanto, , Japan

Site Status

Kinki Region

Kinki, , Japan

Site Status

Kyushu Region

Kyushu, , Japan

Site Status

Shikoku Region

Shikoku, , Japan

Site Status

Tohoku Region

Tohuku, , Japan

Site Status

Countries

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Japan

Other Identifiers

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ONO-5046Na-14

Identifier Type: -

Identifier Source: org_study_id

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