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

Phase 2

Completed

• Conditions: Community-acquired Pneumonia
• Interventions: Drug: ONO-5046Na

• Registration Number: NCT00417326
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-28
• Study First Submitted QC: 2006-12-28
• Study First Posted: 2007-01-01
• Primary Completion: 2009-08
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

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

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Exclusion Criteria

• Patients with nosocomial pneumonia
• Patients on mechanical ventilation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P	ONO-5046Na	-
E	ONO-5046Na	-

Primary Outcome Measures

Name	Time	Method
pulmonary function	14 days

Secondary Outcome Measures

Name	Time	Method
mortality	28 days
ventilator status	28 days

Trial Locations

Locations (9)

Chugoku Region; 🇯🇵 Chugoku, Japan

Hokkaido Region; 🇯🇵 Hokkaido, Japan

Hokuriku Region; 🇯🇵 Hokuriku, Japan

Shikoku Region; 🇯🇵 Shikoku, Japan

Tohoku Region; 🇯🇵 Tohuku, Japan

Chubu Region; 🇯🇵 Chubu, Japan

Kanto Region; 🇯🇵 Kanto, Japan

Kyushu Region; 🇯🇵 Kyushu, Japan

Kinki Region; 🇯🇵 Kinki, Japan